Quality Systems Associate

Grifols•Hattiesburg, MS

4d•Onsite

About The Position

Under the direct supervision of the Quality Systems Manager, the Quality Systems Associate performs quality assurance and training functions to support compliance with internal and external regulations, protocols, cGMP requirements, and standard operating procedures. The role reviews quality, product-release, donor, equipment, and training documentation; investigates quality issues; and helps ensure donor safety and product quality at a plasma center. The associate maintains and audits training records, observes employee training to confirm competency, and conducts required training related to center notifications, corporate directives, and SOP changes or implementations. When the Quality Systems Manager is absent, the associate may review and approve deferred donor reinstatements and assist with internal donor center audits. The role also reviews monthly trending reports and donor adverse-event documentation and conducts training addressing corrective and preventive measures. Work is performed in a plasma center and involves extensive documentation review while sitting, as well as standing and other movement. The work environment includes potential exposure to biological fluids and infectious organisms, office and laboratory equipment, and extreme cold in plasma freezers. Required personal protective equipment includes protective eyewear, garments, gloves, and cold gear. The position requires Donor Center Technician certification and the ability to work flexible schedules to meet business needs.

Requirements

High school diploma or GED.
Typically requires no previous related experience.
Obtain state licensures or certifications if applicable.
Be certified and maintain certification as a Donor Center Technician.
Ability to understand FDA regulations and follow SOPs and protocols.
Basic understanding of cGMP and quality systems.
Developing interpersonal communication, organizational, and problem-solving skills.
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 carry out the primary responsibilities of the Quality Associate role proficiently.
Good organizational skills and attention to detail.
Ability to sit for documentation review and work independently with little guidance or reliance on oral or written instructions.
Ability to perform a wide range of tasks amid variable demands and changing conditions and communicate sensitive information to diverse groups.
Hearing acuity; color perception and discrimination; near and far vision correctable to 20/30 in one eye and 20/100 in the other.
Frequent hand and foot movement; ability to make quick, simple finger, hand, and wrist movements and precise coordinated finger movements to grasp and manipulate objects.
Ability to lift 15 pounds routinely, with a maximum lift of 50 pounds; reach below shoulder height; occasionally walk, bend, and twist at the waist; and rarely squat, crouch, or sit on one's heels.
Ability to sit for 4 to 6 hours per day, stand for 2 to 4 hours per day, and bend or twist the neck for 2 to 4 hours per day.

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 requirements before use.
Review documentation for unsuitable test results.
Assist the Quality Systems Manager in ensuring compliance with cGMP regulations, SOPs, and other regulatory requirements.
Perform product-release activities.
Review lookback information and documentation, waste shipment documentation, and unexpected plasmapheresis events and associated donor-chart documentation.
Review electronic donor-chart exceptions affecting donor eligibility, donor safety, or product quality, and review donor-deferral notifications from competitor centers.
Review plasma-processing documentation to verify proper product freezing, storage, and handling.
Create, maintain, and audit training records and files for compliance.
Observe employee training and verify staff 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 related documentation.
Conduct training to address donor center corrective and preventive measures.
Maintain certification as a Donor Center Technician.
Communicate issues identified during reviews to the CQM.
Perform other duties as assigned by managers or supervisors.