Quality Systems Associate
About The Position
Under the direct supervision of the Quality Systems Manager, the Quality Systems Associate performs quality assurance and training functions to ensure compliance with internal and external regulations and protocols. The role supports quality systems and training programs at a plasma center, including documentation review, product release, investigations, employee competency checks, and compliance with cGMP regulations, SOPs, and regulatory requirements. The associate is certified and maintains certification as a Donor Center Technician. When the Quality Systems Manager is absent, the associate may occasionally review and approve deferred donor reinstatements and assist with internal donor center audits.
Requirements
- High school diploma or GED.
- Typically requires no previous related experience.
- Obtain applicable state licensures or certifications.
- 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.
- Computer proficiency.
- Ability to work flexible schedules to meet business needs.
- Ability to perform basic document reviews and employee observations.
- Ability to communicate issues noted during reviews to the CQM.
- Basic understanding of cGMP and quality systems.
- Ability to perform the primary responsibilities of the Quality Associate role proficiently.
- Good organizational skills and attention to detail.
- Ability to spend hours sitting and reviewing documentation for accuracy.
- Ability to work independently with little guidance and handle variable tasks and changing conditions.
- Ability to communicate sensitive information to diverse groups.
Responsibilities
- Review equipment quality-control and maintenance records weekly.
- Document and investigate deviations and customer complaints, including root-cause analysis 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.
- Support 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 for 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.
- Help ensure 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 work independently.
- Conduct 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 internal donor center audits.
- Review monthly trending reports.
- Review donor adverse-event reports and related documentation.
- Conduct training to address donor center corrective and preventive 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
