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, protocols, and center procedures. The role reviews quality and donor documentation, supports product release, investigates quality issues, and helps ensure plasma is properly processed, stored, and handled. The associate maintains and audits training records, observes employee training to verify competency, and conducts required training related to center notifications, corporate directives, and SOP changes or implementations. When the Quality Systems Manager is absent, the associate may review and approve deferred donor reinstatements and assist with internal donor center audits. The role also reviews monthly trend reports and donor adverse-event documentation, and provides training on corrective and preventive measures. Work takes place in a plasma center and involves exposure to biological fluids, potential infectious organisms, electrical office and laboratory equipment, and temperatures below 32°F in plasma freezers. Required protective equipment includes protective eyewear, garments, gloves, and cold-weather gear. The position involves extended periods of sitting and standing, documentation review, frequent hand and finger movements, occasional bending and twisting, and lifting up to 50 pounds. The associate must be certified and maintain certification as a Donor Center Technician.
Requirements
- High school diploma or GED.
- Typically requires no previous related experience.
- Obtain applicable state licensures or certifications.
- Ability to understand FDA regulations and follow SOPs and protocols.
- Basic understanding of cGMP and quality systems.
- Ability to perform basic document review and employee observations and to carry out primary Quality Associate responsibilities proficiently.
- Developing interpersonal communication, organizational, and problem-solving skills.
- 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.
- Good organizational skills and attention to detail.
- Ability to sit and review documentation for accuracy for extended periods.
- Ability to work independently with little guidance and handle variable demands and changing conditions.
- Ability to communicate information clearly, listen to and understand spoken information, and relate sensitive information to diverse groups.
- Ability to meet the described physical and sensory demands, including lifting up to 50 pounds, frequent hand movements, and required hearing and vision acuity.
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 fail to 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, waste shipment documentation, and unexpected plasmapheresis events and related donor-chart documentation.
- Review electronic donor-chart exceptions that affect donor eligibility, safety, or product quality, and review donor deferral notifications from competitor centers.
- Review plasma-processing documentation to ensure proper freezing, storage, and handling.
- Create, maintain, and audit training records and files.
- Observe employee training to verify competency before employees 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 internal donor center audits.
- Review monthly trending reports and donor adverse-event reports and related documentation.
- Conduct training addressing donor center corrective and preventive measures.
- Maintain certification as a Donor Center Technician.
- Communicate issues identified during reviews to the CQM.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
