Quality Systems Associate
About The Position
The Quality Systems Associate performs quality assurance and training functions under the direct supervision of the Quality Systems Manager to ensure compliance with internal and external regulations, protocols, cGMP requirements, and standard operating procedures. The role is based in a plasma center and includes reviewing quality, donor, product, and training documentation; investigating quality issues; supporting product release; and helping maintain staff competency and compliance. When the Quality Systems Manager is absent, the associate may occasionally review deferred donor reinstatements and assist with the internal donor center audit. The position also requires maintaining certification as a Donor Center Technician.
Requirements
- High school diploma or GED.
- Obtain applicable state licensures or certifications.
- Typically requires no previous related experience.
- Developing interpersonal communication, organizational, and problem-solving skills.
- Ability to understand FDA regulations and follow SOPs and protocols.
- Strong integrity and commitment to quality and compliance.
- Good knowledge of mathematics and legible handwriting.
- Proficiency with computers.
- Ability to work flexible schedules to meet business needs.
- Ability to perform basic document reviews and employee observations and communicate issues noted during reviews to the CQM.
- Basic understanding of cGMP and quality systems.
- Ability to perform primary responsibilities of the Quality Associate role proficiently.
- Good organizational skills and attention to detail.
- Ability to sit and review documentation for accuracy for hours at a time.
- Ability to work independently with little guidance and handle variable demands and changing conditions.
Responsibilities
- Review equipment quality-control and maintenance records weekly.
- Document and investigate deviations and customer complaints, and perform root-cause analysis, especially when related to product quality or donor safety.
- Inspect and release incoming supplies; investigate and report supplies that do not meet quality specifications before use.
- Review documentation for unsuitable test results.
- Assist the Quality Systems Manager in ensuring compliance with cGMP regulations, SOPs, and regulatory requirements.
- Perform product release activities.
- Review lookback information and documentation.
- Review waste shipment documentation.
- Review unexpected plasmapheresis events, including electronic donor charts and related documentation concerning exceptions during donation.
- Review electronic donor chart exceptions affecting donor eligibility, donor safety, or product quality.
- Review donor deferral notifications from competitor centers.
- Review plasma processing documentation to ensure proper freezing, storage, and handling of product.
- Assist the Quality Systems Manager in ensuring center training programs follow procedural requirements in donor center SOPs and training program documents.
- Create, maintain, and audit training records and files for compliance.
- Observe employee training to verify staff competency before employees are released to work independently.
- Conduct required training for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
- When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with the internal donor center audit.
- Review monthly trending reports.
- Review donor adverse-event reports and applicable related documentation.
- Conduct training to address donor center corrective and preventative measures.
- Maintain certification as a Donor Center Technician.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
