Quality Systems Associate

GRIFOLS, S.A.•Statesboro, GA

2d•Onsite

About The Position

The Quality Systems Associate works under the direct supervision of the Quality Systems Manager to perform quality assurance and training functions and help ensure compliance with internal and external regulations, protocols, cGMP requirements, and SOPs. The role is based in a plasma center and includes reviewing quality records, donor and product documentation, supplies, training records, and adverse-event information. When the Quality Systems Manager is absent, the associate may occasionally review and approve deferred donor reinstatements and assist with the internal donor center audit. The associate is certified and maintains certification as a Donor Center Technician.

Requirements

High school diploma or GED.
Typically requires no previous related experience.
Obtain applicable state licensure or certifications.
Developing interpersonal communication, organizational, and problem-solving skills.
Ability to understand FDA regulations, follow SOPs and protocols, and demonstrate a basic understanding of cGMP and quality systems.
Strong integrity and commitment to quality and compliance.
Good knowledge of mathematics and legible handwriting.
Computer proficiency.
Ability to work a flexible schedule to meet business needs.
Ability to perform basic document reviews and employee observations and to perform the primary responsibilities of the Quality Associate role proficiently.
Ability to communicate openly with the CQM about issues identified during reviews.
Good organizational skills and attention to detail.
Ability to sit for extended periods while reviewing documentation.
Ability to work independently with little guidance and handle variable demands and changing conditions.
Ability to communicate and understand spoken information and relate sensitive information to diverse groups.

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 or requirements 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 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 product freezing, storage, and handling.
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, occasionally review and approve deferred donor reinstatement activities and assist with the internal donor center audit.
Review monthly trending reports.
Review donor adverse-event reports and related documentation.
Conduct training to address donor center corrective and preventive measures.
Maintain certification as a Donor Center Technician.