Quality Control Technical Writer

  • Torrent Pharma Inc.
  • Levittown, PA, USA
  • Aug 09, 2021
Full time Quality Control

Job Description

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