Quality Systems Associate

Grifols•Inkster, MI

5h•Onsite

About The Position

Under the direct supervision of the Quality Systems Manager, the Quality Systems Associate performs quality assurance and training functions to support compliance with internal and external regulations, protocols, cGMP requirements, and SOPs. The role includes reviewing quality and donor documentation, investigating deviations and complaints, releasing products, inspecting supplies, and supporting the donor center’s training program. The associate must be certified and maintain certification as a Donor Center Technician. The position is performed in a plasma center. Work includes extended periods of documentation review, exposure to biological fluids and laboratory or office equipment, and occasional work in plasma freezers at temperatures below 32°F. Required personal protective equipment includes protective eyewear, garments, gloves, and cold-weather gear.

Requirements

High school diploma or GED.
Typically requires no previous related experience.
Obtain applicable state licensures or certifications.
Understand FDA regulations and follow SOPs and protocols.
Maintain a strong commitment to integrity, quality, and compliance.
Demonstrate developing interpersonal communication, organizational, and problem-solving skills.
Have good mathematical knowledge, legible handwriting, and computer proficiency.
Demonstrate basic understanding of cGMP and quality systems.
Perform basic document reviews and employee observations, and perform the primary responsibilities of the Quality Associate role proficiently.
Work flexible schedules to meet business needs.
Be able to sit and review documentation for accuracy for several hours.
Meet the stated occupational demands, including light lifting up to 15 pounds and maximum lifting up to 50 pounds, frequent hand and foot movements, and occasional bending, twisting, walking, squatting, or crouching.
Have essential hearing acuity and the stated correctable near- and far-vision capabilities, including color perception and discrimination.
Communicate information clearly, listen to and understand spoken information, work independently with little guidance, adapt to variable demands and changing conditions, and relate sensitive information to diverse groups.

Responsibilities

Complete weekly reviews of equipment QC and maintenance records.
Document and investigate deviations and customer complaints, including root-cause analysis related to product quality or donor safety.
Inspect and release incoming supplies, and investigate and report supplies that do not meet quality specifications before use.
Review documentation for unsuitable test results.
Perform all product release activities.
Review lookback information and documentation, waste shipment documentation, monthly trending reports, donor adverse event reports, and related documentation.
Review unexpected plasmapheresis events, electronic donor charts, and documentation related to exceptions during the donation process.
Review donor chart exceptions that may affect donor eligibility, safety, or product quality, and review donor deferral notifications from competitor centers.
Review plasma processing documentation to verify proper freezing, storage, and product handling.
Assist the Quality Systems Manager in ensuring cGMP regulations, SOPs, and regulatory requirements are followed.
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.
Conduct training to address donor center corrective and preventative measures.
When the Quality Systems Manager is absent, may review and approve deferred donor reinstatement activities and assist with the internal donor center audit.
Communicate issues identified during reviews to the CQM.
Obtain and maintain certification as a Donor Center Technician.