Quality Systems Associate

Quality Systems Associate 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 and protocols. The role supports center quality systems, document review, deviations, product release, and training activities related to plasma processing and donor safety. Primary Responsibilities Complete weekly review of equipment quality control and maintenance records. Investigate and perform root‑cause analysis for deviations and customer complaints related to product quality and donor safety. Inspect and release incoming supplies; investigate and report supplies that do not meet quality specifications. Review documentation for unsuitable test results. Assist the Quality Systems Manager in ensuring cGMP regulations, SOPs, and regulatory requirements are followed. Perform all product release activities. Review lookback information and documentation. Review waste shipment documentation. Review unexpected plasmapheresis events, including electronic donor charts and related documentation. Review electronic donor chart exceptions impacting donor eligibility, safety, or product quality. Review donor deferral notifications from competitor centers. Review plasma processing documentation to ensure proper freezing, storage, and handling of product. Training and Quality System Support Assist the Quality Systems Manager to ensure center training programs follow procedural requirements. Create, maintain, and audit training records and files to ensure compliance. Perform employee training observations to ensure staff competency before releasing employees to work independently. Conduct required training activities 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 audit completion. Additional Responsibilities Maintain certification as a Donor Center Technician. Conduct monthly trending report reviews. Review donor adverse event reports and related documentation. Conduct training to address donor center corrective and preventive measures. Knowledge, Skills, and Abilities Strong interpersonal communication, organizational, and problem‑solving skills. Understanding of FDA regulations and cGMP principles. Integrity and commitment to quality and compliance. Basic mathematics and legible handwriting. Proficiency with computers and flexible scheduling. Ability to perform basic document review and employee observations. Excellent organizational skills and attention to detail. Education and Experience High school diploma or GED. State licensures or certifications, if applicable. Typically requires no previous related experience. Occupational Demands Work is performed in a plasma center with exposure to biological fluids and potential infectious organisms. The position involves using electrical office and laboratory equipment, exposure to extreme cold below 32°F while reviewing plasma in freezers, and wearing personal protective equipment such as eyewear, garments, gloves, and cold‑gear. The role requires sitting for 4–6 hours per day, standing 2–4 hours per day, frequent hand and foot movements, bending, twisting, and light lifting up to 15 lbs (maximum 50 lbs). Visual acuity and color discrimination requirements include near vision of 20/30 and far vision of 20/100 in one eye, or corrected to 20/30 in both. The position demands independent work with minimal guidance and the ability to communicate clearly with diverse groups. EEO Statement Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth, or related medical conditions, protected veteran status, or disability. All qualified applicants will be considered in a manner consistent with applicable laws. Location NORTH AMERICA : USA : TX-FT Worth:USFTWOR - Ft Worth TX-Rosedale St-BIO #J-18808-Ljbffr