Quality Systems Associate

GRIFOLS, S.A.•Coral Springs, FL

19h•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 other regulatory requirements. The role is based in a plasma center and includes reviewing product, donor, equipment, supply, and training documentation, investigating quality issues, and supporting employee competency and center training programs. The associate may occasionally perform deferred donor reinstatement reviews and assist with the internal donor center audit when the Quality Systems Manager is absent. The position requires maintaining certification as a Donor Center Technician. Work involves extended periods of documentation review, exposure to biological fluids and laboratory equipment, and occasional work in plasma freezers below 32°F. Required personal protective equipment includes protective eyewear, garments, gloves, and cold gear.

Requirements

High school diploma or GED.
Typically, no previous related experience is required.
Obtain applicable state licensures or certifications.
Maintain certification as a Donor Center Technician.
Developing interpersonal communication, organizational, and problem-solving skills.
Ability to understand FDA regulations and follow SOPs and protocols.
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.
Ability to communicate issues identified during reviews to the CQM.
Basic understanding of cGMP and quality systems.
Ability to perform the primary responsibilities of the Quality Associate role proficiently.
Good organizational skills and attention to detail.
Ability to sit and review documentation for accuracy for several hours.
Ability to communicate and listen effectively, work independently with little guidance, perform tasks amid changing demands and conditions, and communicate sensitive information to diverse groups.
Ability to meet the physical demands described, including sitting, standing, bending, twisting, frequent hand and foot movements, occasional squatting or crouching, walking, and lifting up to 50 pounds.
Ability to work around biological fluids, potential infectious organisms, electrical office and laboratory equipment, and extreme cold in plasma freezers; use required protective eyewear, garments, gloves, and cold gear.
Required hearing acuity and correctable near and far vision; color perception and discrimination.

Responsibilities

Review equipment quality-control and maintenance records weekly.
Document, investigate, and perform root-cause analysis for deviations and customer complaints related to product quality or donor safety.
Inspect and release incoming supplies; investigate and report supplies that do not 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 related to donation-process exceptions.
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 verify staff competency before employees are released to work independently.
Conduct 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.
Review donor adverse-event reports and related documentation.
Conduct training to address donor center corrective and preventative measures.
Maintain certification as a Donor Center Technician.
Perform other duties as assigned by managers or supervisors.