Quality Systems Associate

GRIFOLS, S.A.•Inkster, MI

2d•Onsite

About The Position

The Quality Systems Associate performs quality assurance and training functions under the direct supervision of the Quality Systems Manager to help ensure compliance with internal and external regulations, protocols, cGMP requirements, SOPs, and regulatory requirements. The position is based in a plasma center and includes reviewing quality, donor, product, and training documentation; investigating quality issues; supporting product release; and maintaining employee training records and competency. The associate may occasionally perform deferred donor reinstatement reviews and assist with internal donor center audits when the Quality Systems Manager is absent. The role also requires certification and maintenance of certification as a Donor Center Technician. Work is performed mostly seated, with some standing and physical tasks, and involves potential exposure to biological fluids, infectious organisms, laboratory and office equipment, and extreme cold in plasma freezers. Required protective equipment includes protective eyewear, garments, gloves, and cold gear.

Requirements

High school diploma or GED.
Typically requires no previous related experience.
Obtain applicable state licensure or certifications.
Ability to understand FDA regulations and follow SOPs and protocols.
Basic understanding of cGMP and quality systems.
Strong integrity and commitment to quality and compliance.
Developing interpersonal communication, organizational, and problem-solving skills.
Good knowledge of mathematics and legible handwriting.
Proficiency with computers.
Ability to perform basic document reviews and employee observations.
Ability to communicate openly with the CQM about issues identified during reviews.
Ability to perform primary responsibilities of the Quality Associate role proficiently.
Good organizational skills and attention to detail.
Ability to work flexible schedules to meet business needs.
Ability to sit and review documentation for accuracy for several hours.
Ability to communicate and understand spoken information, relate sensitive information to diverse groups, and work independently with little guidance.
Ability to perform physical duties that include frequent hand and foot movements, precise finger coordination, occasional walking, bending, twisting, reaching below shoulder height, and light lifting of 15 pounds with a maximum lift of 50 pounds.
Hearing acuity and color perception/discrimination; near and far vision must be correctable to 20/30 in one eye and 20/100 in the other eye.

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 fail to 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 documentation of exceptions during donation.
Review electronic donor chart exceptions that may affect 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 confirm 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 as needed.
When the Quality Systems Manager is absent, assist with completion of 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 preventive measures.
Maintain certification as a Donor Center Technician.