Quality Systems Associate

Grifols•Springs, FL

11d•Onsite

About The Position

Under the direct supervision of the Quality Systems Manager, the Quality Systems Associate performs quality assurance and training functions to ensure compliance with internal and external regulations, protocols, cGMP requirements, and SOPs. The role reviews product, donor, equipment, supply, and training documentation and supports quality investigations and center training programs. The associate performs product release activities; reviews plasma processing and storage documentation, lookback information, waste shipment records, donor chart exceptions, donor deferral notifications, adverse-event reports, and monthly trending reports. The role also inspects and releases incoming supplies and investigates deviations, customer complaints, and supplies that do not meet requirements. The associate creates and audits training records, conducts employee observations and required training, and may support donor reinstatements and internal audits when the Quality Systems Manager is absent. The position is based in a plasma center. Work involves sitting and standing, reviewing documentation, and potential exposure to biological fluids, laboratory and office equipment, and temperatures below 32°F in plasma freezers. Required personal protective equipment includes protective eyewear, garments, gloves, and cold gear. The associate must maintain certification as a Donor Center Technician.

Requirements

High school diploma or GED.
Typically no previous related experience is required.
Obtain state licensure or certifications if applicable.
Ability to understand FDA regulations and follow SOPs and protocols.
Strong integrity and commitment to quality and compliance.
Developing interpersonal communication, organizational, and problem-solving skills.
Good knowledge of mathematics and legible handwriting.
Computer proficiency.
Ability to work flexible scheduling 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.
Basic understanding of cGMP and quality systems.
Organizational skills and attention to detail.
Ability to sit and review documentation for hours and to perform the physical demands described, including light lifting of 15 pounds and a maximum lift of 50 pounds.
Hearing acuity; color perception and discrimination; near and far vision correctable to 20/30 in one eye and 20/100 in the other.
Ability to communicate and understand spoken information, work independently with little guidance, adapt to variable demands, and relay sensitive information to diverse groups.

Responsibilities

Complete weekly reviews of equipment quality-control 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; investigate and report supplies that fail to meet quality specifications before use.
Perform documentation review for unsuitable test results.
Assist the Quality Systems Manager in ensuring compliance with cGMP regulations, SOPs, and regulatory requirements.
Perform all product release activities.
Review lookback information and documentation, waste shipment documentation, and unexpected plasmapheresis events and related records.
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.
Assist the Quality Systems Manager in ensuring center training programs follow procedural requirements.
Create, maintain, and audit training records and files.
Conduct employee training observations to verify competency before employees 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 internal donor center audits.
Review monthly trending reports and donor adverse-event reports and their related documentation.
Conduct training to address donor center corrective and preventative measures.
Maintain certification as a Donor Center Technician.
Communicate issues identified during reviews to the CQM.