222 Quality Control jobs

The Quality Management Systems (QMS) Associate Director or Director oversees and actively participates in all aspects pertaining to Deviations, Investigations, Complaints, CAPA, Internal/External and Regulatory Audits, commitment tracking, and DEA. The QMS Associate Director/Director must be able to thoroughly and accurately complete/assist in the investigation of incidents / events which have occurred during the manufacturing, packaging, testing and storage of pharmaceutical products for determination of root cause and product impact per FDA regulations. In addition, he/she ensures that corrective and preventive actions (CAPA) based on investigation findings are identified and implemented to prevent occurrence/reoccurrence of the events. The QMS Associate Director/Director will report to the Head of Quality and will efficiently conduct all duties and responsibilities assigned and or delegated by the Head of Quality. Essential Duties and Responsibilities: Lead and direct all QMS, Compliance and DEA related activities including but not limited to Deviations/Investigations, Complaints, CAPA, Change Control, OOS, Laboratory Investigations, Data Review, Internal/External/Regulatory Audits, and DEA quota, inventory and registrations. Ensures all investigations are extended to other batches or products as needed and completed in a timely manner. Oversees the implementation of the appropriate corrective and preventive actions (CAPA) to prevent occurrence/reoccurrence. Manage Effectiveness Checks to ensure they are performed by the required due date. Performs GAP analyses and risk assessments, and proactively implements quality policies and procedures in accordance with CGMP, and other regulatory requirements. Assists the Head of Quality in facilitating audits conducted by regulatory agencies, customers, and clients. Writes and prepares responses to audit findings by regulatory agencies, customers, and clients. Manages internal and external audit program; prepares yearly audit schedule. Reviews audit reports and responses for accuracy and completeness and provides follow-up on corrective actions and commitments. Manages customer complaints program. Reviews and approves complaint investigation reports and corrective actions. Manages investigations, audits and commitment tracking. Reviews and approve commitments. Provides training and guidance on conducting investigations and root cause analysis. Reviews and approves investigations for adequacy of root cause determination and CAPA. Makes decisions on disposition of Raw Materials, Finished Products, Components, Equipment impacted by the investigations. Guides other cross functional areas and prepares risk assessments. Prepares monthly metrics, trending charts, and meeting minutes. Escalates quality and Compliance issues in a timely manner. Evaluates and enhances site wide and departmental procedures and policies to ensure compliance with CGMPs, company policies, and other regulatory bodies Reviews and approves change controls, investigation, validation and qualification protocols and reports. Manages DEA reporting, cages, vaults in accordance with DEA regulations. Maintains all regulatory certifications, licenses, registrations including DEA. Manages within the allocated budget and resources Acts as a liaison between all cross functional departments to resolve compliance issues Provide guidance to other departments and serve as subject matter expert (SME) on the performance of investigations and in the use of Root Cause Analysis Tools Maintain knowledge of current regulatory requirements pertaining to pharmaceutical products Maintain effective communication and partnership with all departments across the organization Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations. Generate and facilitate changes to SOPs, policies, training materials, and other documents to assure compliance and continuous improvement. Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues. Proactive, good organizational and time management skills Follow and enforce GMP and GDP and applicable Standard Operating Procedures. Report any concerns immediately to Management. Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested. Interact with any and all other departments to resolve any issues regarding QMS Other duties may be assigned by the Head of Quality Safety Requirements: Ensure adherence to all personal protective equipment: Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources Competencies/Skills: Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word. Strong organizational skills and the ability to multitask Demonstrated ability in working independently and as part of a team. Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Excellent communication (oral and written) and interpersonal skills Must be able to communicate technical, scientific, and regulatory information, both written and verbally Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance. Education and/or Experience: Bachelor’s degree; Degree in Chemistry, Biology or related science is preferred. Minimum of ten (10) years of experience working in a GMP environment. Minimum of ten (10) years of experience in a Quality role in a pharmaceutical manufacturing environment. Lean, Six Sigma and cGMP experience preferred. Language Skills: ability to read and comprehend instructions in the English language through verbal and written method. ability to write or speak in the English language information effectively in one-on-one and in group of employees within the organization. Mathematical Skills: ability to interpret data utilizing intermediate math operations; statistical analysis Reasoning Ability: ability to apply common sense understanding to carry out multi-step instructions deal with standardized situations with occasional variables Physical Demands : Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. **Applicants must be able to commute daily to this location - - we are not currently offering any relocation**

The Quality Management Systems (QMS) Manager or Sr. Manager oversees and actively participates in all aspects pertaining to Deviations, Investigations, Complaints, and CAPA. The QMS Manager/Sr. Manager must be able to thoroughly and accurately complete/assist in the investigation of incidents / events which have occurred during the manufacturing, packaging, testing and storage of pharmaceutical products for determination of root cause and product impact per FDA regulations. In addition, he/she ensures that corrective and preventive actions (CAPA) based on investigation findings are identified and implemented to prevent occurrence/reoccurrence of the events. The QMS Manager/Sr. Manager will report to the Head of QMS and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of QMS and Compliance or the Site Head of Quality.         Essential Duties and Responsibilities: Review and/or conduct thorough investigations and act as the Investigation Team Lead for Incidents/Deviations, OOS Investigations, Laboratory Events and Product Complaint Investigations as required following appropriate company procedures. Ensure all investigations are completed in a timely manner to support product release and regulatory compliance Ensure that all Incidents/Deviations, OOSs, Laboratory Events and Product Complaints are documented and tracked according to procedures. Identify and oversee the implementation of the appropriate corrective and preventive actions (CAPA) to prevent occurrence/reoccurrence. Provide guidance to other departments and serve as subject matter expert (SME) on the performance of investigations and in the use of Root Cause Analysis Tools Manage CAPAs to ensure timely closure of actions resulting from various types of investigations. Provide metrics as requested to track/trend Incident, Event/Deviations, CAPA and Complaints. Manage Effectiveness Checks to ensure they are completed by the required due date and perform closure of Effectiveness Checks. Provide training on conducting investigations and performing root cause analysis as needed. Assist during regulatory inspections or other audits, as required Maintain knowledge of current regulatory requirements pertaining to pharmaceutical products Initiate SOP revisions as needed to assure compliance and continuous improvement. Maintain effective communication and partnership with all departments across the organization Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations. Generate and facilitate changes to SOPs, policies, training materials, and other documents. Ensure all work is performed and documented in accordance with GMP requirements and existing company policies and procedures. Assist staff regarding QMS processes. Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues. Proactive, good organizational and time management skills Follow and enforce GMP and GDP and applicable Standard Operating Procedures. Report any concerns immediately to Management. Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested. Interact with any and all other departments to resolve any issues regarding QMS documents Other duties may be assigned by the Head of QMS and Compliance, or Site Head of Quality   Safety Requirements: Ensure adherence to all personal protective equipment: Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word. Strong organizational skills and the ability to multitask         Demonstrated ability in working independently and as part of a team. Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Excellent communication (oral and written) and interpersonal skills Must be able to communicate technical, scientific, and regulatory information, both written and verbally Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance.                                 Education and/or Experience:                                                    Bachelor’s degree; Degree in Chemistry, Biology or related science is preferred. Minimum of five (5) years of experience working in a GMP environment. Minimum of five (5) years of experience in a Quality role in a pharmaceutical manufacturing environment. Lean, Six Sigma and cGMP experience preferred.   Language Skills:                                                              ability to read and comprehend instructions in the English language through verbal and written method. ability to write or speak in the English language information effectively in one-on-one and in group of employees within the organization.   Mathematical Skills:                                                       ability to interpret data utilizing intermediate math operations; statistical analysis   Reasoning Ability:                                                          ability to apply common sense understanding to carry out multi-step instructions deal with standardized situations with occasional variables   Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.   Work Environment: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. noise level in the work environment is usually moderate, but may be loud at times.

The major responsibility of the Quality Control Laboratory Technician is to provide support to various laboratory functions including cleaning of laboratory glassware, maintaining laboratory cleanliness and tidiness, ordering laboratory supplies, chemicals and reagents. The Quality Control Laboratory Technician will maintain inventory for laboratory supplies, perform daily verification of laboratory equipment and basic Wet Chemistry testing.  Responsibilities will also include receiving in-coming samples in the laboratory and preparing samples and paperwork for outside testing. The Quality Control Laboratory Technician will report to the Quality Control Laboratory Group Lead and efficiently conduct all duties and responsibilities assigned, and/or delegated by the Head of Quality Control Laboratory or the Site Head of Quality.       Essential Duties and Responsibilities: Responsibilities include the following, but are not limited to: Perform daily verification and or calibration of laboratory equipment, i.e. pH meter, Balance, Karl fisher Receive and log incoming samples in the logbook Perform basic Wet Chemistry testing Preparation of solution, solvents and mobile phases Accurately documenting all tests/test materials/equipment used and all results obtained Work in accordance with approved methods, SOPs and cGMP/GLP and GDPs while performing tests Preparation of packaging components, Raw material, finished product, stability samples and related request form for outside laboratory testing Cleaning and organizing the laboratory glassware Maintain the laboratory in clean and organize manner Ordering laboratory supplies, chemicals and reagent Moving of sample and chemical waste to designated area for destruction. Adheres to safety regulation and OSHA procedure. Executes assigned tasks within established timelines Complies with company policies, procedures, rules and regulations Maintains confidently and communicates effectively Works with computers as well as laboratory software as needed   ADDITIONAL RESPONSIBILITIES: Maintains and demonstrates a high level of personal and professional integrity Reports any suspicious activity to laboratory management Assists Laboratory Management on special projects and assignments Additional responsibilities may be assigned by Laboratory Management as needed   QUALITICATIONS: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed represent the knowledge, skills, and ability required for this role.   Safety Requirements: Ensure adherence to all personal protective equipment Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word Ability to work independently and as part of team, self-motivation, adaptability and positive attitude Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Ability to work in a detail-oriented manner Ability to meet attendance standards: All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.   Education and Experience: Bachelor’s degree in Science Field, Chemistry Degree preferred one or more years of experience GMP laboratory environment Experience and knowledge of basic laboratory operations such as weighing and preparing solution Ability to follow laboratory procedure with technical content, quality and safety with instruction Must have knowledge of safe handle of chemicals and reagents Must be able to operate a laboratory glassware washer                 Language Skills:                                                              Ability to read and comprehend instructions in the English language through verbal and written methods. Ability to write or speak in the English language and communicate information effectively in one-on-one and groups within the organization.   Mathematical Skills:                                                      Ability to interpret data utilizing intermediate math operations Ability to perform simple analytical calculations   Reasoning Ability:                                                         Ability to apply common sense understanding to carry out multi-step instructions Ability to deal with standardized situations including occasional variables   Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl, and talk or hear Frequently lift and/or move up to 25 pounds Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus   Work Environment: Noise level in the work environment is usually moderate but may be loud at times

The Compliance Associate oversees and conducts internal and external audits. Routine job responsibilities include the evaluation of all departments and associated documentation for adherence to Torrent procedures and regulatory requirements as well as providing support during regulatory or customer audits of Torrent Pharma. The Compliance Associate/Senior Associate will report to the Head of QMS and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of QMS and Compliance or the Site Head of Quality.       Essential Duties and Responsibilities: Prepare the annual schedule for internal audits, conduct and document internal audits, track and provide follow-up on corrective actions Work closely with personnel in all departments ensuring procedures are being followed and documentation requirements are being performed as required to ensure product quality and compliance to company procedures and regulatory requirements Support external, regulatory or certification audits and interact with FDA as needed Coordinate interdepartmentally and draft responses to external and regulatory audits Identify and oversee the implementation of the appropriate corrective and preventive actions (CAPA) to prevent deviation occurrence/reoccurrence Manage CAPAs to ensure timely closure of actions resulting from various types of audits Track and provide follow-up to corrective actions and commitments pertaining to external and regulatory audits Manage Effectiveness Checks to ensure they are completed by the required due date and perform closure of Effectiveness Checks Provide metrics as requested to track/trend audit observations Performs analysis of key quality indicators and analyzes data to identify areas for improvement in the quality system Generates and facilitates changes to SOPs, policies, training materials, and other documents to assure compliance and continuous improvement. Assists in the QA review of investigations, root cause analysis, and Corrective and Preventive Action (CAPA) plans related to process / product deviations, material testing, and Out-of-Specification events Notifies management of quality/compliance trends. Maintains knowledge of current regulatory requirements pertaining to pharmaceutical products Maintains effective communication and partnership with all departments across the organization Maintains a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations. Ensure all work is performed and documented in accordance with GMP requirements and existing company policies and procedures Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues. Proactive, good organizational and time management skills Follow and enforce GMP and GDP and applicable Standard Operating Procedures. Report any concerns immediately to Management. Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested Interact with any and all other departments to resolve any issues regarding internal/external audits Other duties may be assigned by the Head of QMS and Compliance, or Site Head of Quality   Safety Requirements: Ensure adherence to all personal protective equipment: Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word. Strong organizational skills and the ability to multitask         Demonstrated ability in working independently and as part of a team Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Excellent communication (oral and written) and interpersonal skills Must be able to communicate technical, scientific, and regulatory information, both written and verbally Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance                                 Education and/or Experience:                                                    Bachelor’s degree; Degree in Chemistry, Biology or related science is preferred. Minimum of three (3) years of experience working in a GMP environment. Minimum of three (3) years of experience in a Quality role in a pharmaceutical manufacturing environment. Lean, Six Sigma and cGMP experience preferred.   Language Skills:                                                              ability to read and comprehend instructions in the English language through verbal and written method. ability to write or speak in the English language information effectively in one-on-one and in group of employees within the organization.   Mathematical Skills:                                                       ability to interpret data utilizing intermediate math operations; statistical analysis   Reasoning Ability:                                                          ability to apply common sense understanding to carry out multi-step instructions deal with standardized situations with occasional variables   Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.   Work Environment: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Noise level in the work environment is usually moderate, but may be loud at times.

The major responsibility of the Quality Control Technical Writer is to write, review, revise and maintain analytical technical documents within the Quality Control Laboratory. The Technical documents include, but are not limited to testing Methods, Specifications, Standard Operating Procedures, Technical Transfer Documents, Method Validation, Verification protocols and reports. The Quality Control, Technical Writer will also manage documentation compliance, change control for the quality control laboratory and will be responsible for writing laboratory deviations and investigations. The Quality Control Technical Writer will report to the Head of Quality Control Laboratory and efficiently conduct all duties and responsibilities assigned, and/or delegated by the Head of Quality Control Laboratory or the Site Head of Quality.       Essential Duties and Responsibilities: Write, review and revise the following documents Analytical Methods and Specifications Pre and Post approval Stability protocols Method Validation, Verification, Transfer, and Experimental Protocols and Reports SOPs pertaining to laboratory equipment and operation Forms, checklists, and training quizzes associated with SOPs Reviews and revises documents prepared by others and coordinates the preparation of those materials for completed documents Reviews and edits complex written technical materials for accuracy, clarity, and completeness Initiates change controls for analytical document implementations and revisions Address comments from SMEs and different stake holders to finalize/approve the analytical documents, and follows up for their approval process in a timely manner to meet the targeted timelines Perform GMP technical data review for analytical activities such as; but not limited to; method validation, method transfer, method verification and testing of Stability Submission batches Support laboratory investigations including, identification of root cause, identification and implementation of appropriate corrective and preventative actions, authoring the final investigation report, and writing the impact assessments Ensure investigations adhere to compliance-driven timelines and are compliant with cGMP regulations Providing quality and technical support to Laboratory Manager, Group Leaders, as well as Scientist and Laboratory Technicians Support key projects for Laboratory Operations aimed at elevating compliance Maintain periodic review of Laboratory SOPs Knowledge of FDA/ICH guidelines with respect to FDA’s current requirements for method validation, verification, transfer, and stability Demonstrates the ability to prioritize conflicting demands Executes assigned tasks within established timelines Develops and maintains expertise in chemistry and pharmaceutics through a professional education and training Complies with company policies, procedures, rules and regulations Maintains confidently and communicates effectively Works with computers as well as laboratory software as needed   Additional Responsibilities: May require technical review of previously generated data for regulatory responses Maintains and demonstrates a high level of personal and professional integrity Reports any suspicious activity to laboratory management Assists Laboratory Management on special projects and assignments Additional responsibilities may be assigned by Laboratory Management as needed   QUALITICATIONS: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed represent the knowledge, skills, and ability required for this role.   Safety Requirements: Ensure adherence to all personal protective equipment Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word Proficient in technical writing Ability to learn quickly, perform multiple tasks simultaneously, keep accurate record, follow instructions and comply with company policies Ability to work independently and as part of team, self-motivation, adaptability and positive attitude Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Must be able to communicate technical, scientific, and regulatory information, both written and verbally Proficient knowledge of USP and ICH guidelines Ability to work in a detail-oriented manner Ability to meet attendance standards: All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.   Education and Experience: Bachelor’s degree or higher in Science Field, Chemistry Degree preferred Three or more years of demonstrated excellence in the field of analytical chemistry Three or more years of experience in writing analytical technical documents Experience troubleshooting Laboratory Deviations Knowledge of cGMP and related compliance regulation and guidance is required Prior experience in a pharmaceutical (cGMP) laboratory setting is required Prior Technical writing experience preferred                Language Skills:                                                                Ability to read and comprehend instructions in the English language through verbal and written methods. Ability to write or speak in the English language and communicate information effectively in one-on-one and groups within the organization.   Mathematical Skills:                                                         Ability to interpret data utilizing intermediate math operations Ability to perform complicated analytical calculations and statistical analysis   Reasoning Ability:                                                           Ability to apply common sense understanding to carry out multi-step instructions Ability to deal with standardized situations including occasional variables   Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl, and talk or hear Frequently lift and/or move up to 25 pounds   Work Environment: Noise level in the work environment is usually moderate but may be loud at times

The major responsibility of the Quality Control Chemist is to perform physical and chemical testing on raw materials, packaging component, in-process, finished products, stability samples, cleaning verification, cleaning validation, process validation following Analytical Methods, Protocols, Procedures (SOPs) and company policies. He/she follows and maintains adherence to current industry standards (cGMPs, GLPs, etc.) to meet production and customer demand. Qualified candidates will be expected to work either independently or as a team to achieve company goals and initiatives. The Quality Control Chemist will report to the Quality Control Laboratory Group Lead and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of Quality Control, Laboratory Manager or the Site Head of Quality.        Essential Duties and Responsibilities: Responsibilities include the following. Other duties may be assigned.   Perform analytical testing of raw materials, in-process, finished product and/or stability samples, cleaning verification, cleaning validation, and process validation following Analytical Methods, Protocols, Procedures (SOPs) and company policies Testing includes, assay, related substance, dissolution, residual solvents, viscosity, pH, Water content, Specific Gravity and other tests according to the analytical methods, USP, procedures in a regulated laboratory environment Analyze samples using appropriate instrumentation such as HPLC, UPLC, GC, Dissolution apparatus, UV, IR, Karl Fisher (KF), pH, Viscometer etc. Perform instrument calibration such as HPLC, UPLC, GC, Dissolution apparatus, UV, IR, Karl Fisher (KF), pH, Viscometer etc. Maintain data within a laboratory notebook in a legible, organized, and compliant manner, and transcribes or enters data into necessary records in an accurate and timely manner Process and report the analysis results using the instrument specific data processing software Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, or other Deviation to Laboratory Management promptly for further investigation Performs investigative testing or other functions to assist with laboratory investigations Follow all SOPs, Safety Guidelines and good housekeeping practices to ensure compliance with cGMP and Housekeeping requirements Identify and troubleshoot problems with instrumentation and analytical preparations Maintain lab work area in a neat and orderly fashion Assists in execution of training and acts as a mentor to less-experienced analysts Works in support of production and development projects and may require weekend, off-shift work, or overtime as necessary to complete high priority work assignments Works with computers as well as laboratory software, or proprietary software as needed   ADDITIONAL RESPONSIBILITIES: Responsibilities for the appropriate documentation and disposal of unused laboratory samples and expired reagents Maintain and demonstrate a high level of personal and professional integrity and Report any suspicious activity to laboratory management Assists Laboratory Management on special projects and assignments Additional responsibilities may be assigned by Laboratory Management as needed QUALITICATIONS: To perform this job successfully, an individual must be able to perform each essential Duty satisfactorily. The requirements listed are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   Safety Requirements: Ensure adherence to all personal protective equipment Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources   Competencies/Skills:   Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word. Strong organizational skills and the ability to multitask         Demonstrated ability in working independently and as part of a team Must be able to work in a cross-functional environment interacting with other internal departments and external vendors Excellent communication (oral and written) and interpersonal skills Ability to meet attendance standards. All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines. Must have a teamwork attitude   Education and/or Experience: Minimum B.S. Degree in Science Field Chemistry Degree Preferred. 1 or more years of experience in an analytical laboratory in pharmaceutical or related field of analytical chemistry Experience in testing raw materials, in-process, finished products and/or stability samples such as assay, related substance, dissolution, residual solvents, viscosity, pH, Water content, Specific Gravity and related testing in an FDA regulated laboratory environment required Basic understanding of cGMPs and compendia procedures where applicable (i.e., USP, NF, BP, etc.) required Demonstrated technical expertise in laboratory instruments, i.e. HPLC, UPLC, GC, UV, Karl Fisher. Experience in instrument calibration i.e. HPLC, UPLC, GC, Dissolution apparatus, UV, IR preferred Experience with Empower or related lab software preferred Prior experience in a pharmaceutical (cGMP) laboratories setting is required                 Language Skills:                                                     Ability to read and comprehend instructions in the English language through verbal and written methods. Ability to write or speak in the English language and communicate information effectively in one-on-one and in a group of employees within the organization.   Mathematical Skills:                                                            Ability to interpret data utilizing intermediate math operations; perform complicated analytical calculations and statistical analysis Reasoning Ability:                                                             Ability to apply common sense understanding to carry out multi-step instructions Deal with standardized situations with occasional variables Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. Frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  Work Environment: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Noise level in the work environment is usually moderate but may be loud at times.

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level 1  Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2  Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3  Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4  Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5  Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6  Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7  Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8  Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9  Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10  Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11  Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12  Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14  Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16  Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17  Assist Plasma center staff in completing other special projects or assignments, as requested. 18  Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors