281 Quality Control jobs

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Primary responsibilities ● Perform daily donor record file review. ● Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual. ● Perform a review of donor center records. ● Perform weekly review of equipment incident logs. ● Verification and release of sample shipment. ● Perform Staging of plasma for shipment. ● Inspection and release of incoming supplies. ● Perform Weekly employee observations. ● Participate in the Quality Assurance meetings and be part of the Quality Assurance team. ● Assist the Center Quality Manager to ensure that cGMP regulations are followed. ● Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met. ● Performs a review of the documentation of unsuitable test results and the disposition of the associated units. ● On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties: ● Performs all product release activities. ● Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Review of equipment records and DMS information if applicable to approve out of service machines for use. ● Review and approval of deferred donor reinstatement activities. ● Perform a review of lookback information ● Waste shipment review ● Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use. ● Perform a review of medical incident reports and the applicable related documentation. Primary Requirements Additional Responsibilities Is certified and maintains certification in the donor processing area. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

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