Quality Systems Associate

Quality Systems Associate

Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols.

• Complete weekly review of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints related to product quality and donor safety.
• Inspect and release incoming supplies; investigate and report supplies that have not met quality specifications before use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure cGMP regulations, SOPs, and regulatory requirements are followed.
• Perform all product release activities.
• Review lookback information and documentation.
• Review waste shipment documentation.
• Review unexpected plasmapheresis events and related electronic donor chart documentation.
• Review electronic donor chart exceptions affecting donor eligibility, safety, and product quality.
• Review donor deferral notifications from competitor centers.
• Review plasma processing documentation to ensure proper freezing, storage, and handling of product.
• Create, maintain, and audit training records and files to ensure compliance.
• Perform employee training observations to ensure staff competence before independent work.
• Conduct required training activities 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 completion of internal donor center audits.

• Maintain certification as a Donor Center Technician.

• Strong interpersonal communication, organizational, and problem‑solving skills.
• Understanding of FDA regulations.
• Integrity and commitment to quality and compliance.
• Proficiency with mathematics and computers.
• Legible handwriting.
• Ability to work flexible scheduling to meet business needs.
• Basic document review and employee observation skills.
• Open communication with the CQM on issues noted during reviews.
• Following SOPs and protocols.
• Ability to perform primary responsibilities proficiently.
• Basic understanding of cGMP and quality systems.
• Ability to spend hours reviewing documentation for accuracy.
• Strong organizational skills and attention to detail.

High school diploma or GED. Obtain state licensures or certifications if applicable.

Typically requires no previous related experience.

Work is performed in a plasma center. Exposure to biological fluids and potential infectious organisms; exposure to electrical office and laboratory equipment; exposure to extreme cold below 32°F during reviews in plasma freezers. Personal protective equipment required including protective eyewear, garments, gloves, and cold‑gear. Work is performed mostly while sitting for up to 4–6 hours per day and standing 2–4 hours per day.

The position requires bending, twisting, and frequent hand, wrist, and foot movements, occasional lifting of up to 15 lbs and a maximum lift of 50 lbs, and some light walking and squatting. Hearing quality required; color perception and vision corrections specified for one eye. Ability to communicate information effectively to diverse groups and to work independently with minimal guidance.

This role’s estimated pay range is $24.48–$33.12 per hour, with eligibility for up to 5% of the company bonus pool. Benefits include medical, dental, vision, life insurance, PTO, paid holidays, up to 5% 401(K) match, and tuition reimbursement.