Quality Systems Associate

GRIFOLS, S.A.•Hattiesburg, MS

About The Position

The Quality Systems Associate performs quality assurance and training functions under the direct supervision of the Quality Systems Manager, helping ensure compliance with internal and external regulations, protocols, cGMP requirements, SOPs, and regulatory requirements. The role is based in a plasma center and includes reviewing quality, donor, product, and training documentation, investigating quality issues, and supporting employee competency and center training programs. The associate reviews equipment quality-control and maintenance records, unsuitable test results, product-release documentation, plasma-processing records, waste shipments, lookback information, donor events and electronic donor-chart exceptions. The role also inspects incoming supplies, investigates deviations and customer complaints, and performs root-cause analysis related to product quality or donor safety. The associate maintains and audits training records, observes employee training and competency, and conducts required training on notifications, directives, and SOP changes. When the Quality Systems Manager is absent, the associate may review deferred donor reinstatements and assist with internal donor center audits. The position also involves reviewing monthly trending reports and donor adverse-event reports and conducting training on corrective and preventive measures. The associate must maintain Donor Center Technician certification.

Requirements

High school diploma or GED.
Typically requires no previous related experience.
Obtain applicable state licensures or certifications.
Maintain certification as a Donor Center Technician.
Understand and follow SOPs and protocols, with a basic understanding of cGMP and quality systems.
Understand FDA regulations.
Demonstrate integrity and commitment to quality and compliance.
Have developing interpersonal communication, organizational, and problem-solving skills.
Have good mathematical knowledge and legible handwriting.
Be proficient with computers.
Demonstrate attention to detail and organizational skills.
Communicate openly with the CQM about issues noted during reviews.
Work independently with little guidance and adapt to variable demands and changing conditions.
Communicate and listen effectively, including when conveying sensitive information to diverse groups.
Work flexible schedules to meet business needs.

Responsibilities

Review equipment quality-control and maintenance records weekly.
Document and investigate deviations and customer complaints and perform root-cause analysis, particularly when 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.
Review waste-shipment documentation.
Review unexpected plasmapheresis events, electronic donor charts, and related documentation concerning exceptions during donation.
Review electronic donor-chart exceptions that 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.
Help ensure center training programs follow 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 and assist with the internal donor center audit.
Review monthly trending reports and donor adverse-event reports and applicable documentation.
Conduct training addressing donor center corrective and preventive measures.
Maintain certification as a Donor Center Technician.