Quality Systems Associate

Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company that has been working since 1909 to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries. Quality Systems Associate Summary: Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols. Responsibilities Complete weekly reviews of equipment QC and maintenance records. Document, investigate, and perform root‑cause analysis for deviations and customer complaints, specifically relating to product quality and/or donor safety. Inspect and release incoming supplies; investigate and report supplies that do not meet quality specifications before use. Perform documentation review for unsuitable test results. Assist the Quality Systems Manager in ensuring cGMP regulation, 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 chart and related documentation of exceptions during donation. Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality. Review donor deferral notifications from competitor centers. Review plasma processing documentation to ensure proper freezing, storage and handling of product. Assist the Quality Systems Manager in ensuring center training programs follow procedural requirements defined in donor center SOPs and training documents. Create, maintain, and audit training records and files to ensure compliance. Perform employee training observations to ensure staff competency before independent work. 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 audits. Review monthly trending reports. Review donor adverse event reports and related documentation. Conduct training to address donor center corrective and preventative measures. Knowledge, Skills and Abilities Strong interpersonal communication, organizational and problem‑solving skills. Ability to understand FDA regulations and cGMP principles. Integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Perform basic document review and employee observations. Communicate openly with the CQM on issues noted during reviews. Follow SOPs and protocols. Spend hours reviewing documents for accuracy. Demonstrate good organizational skills and attention to detail. Education High school diploma or GED; obtain state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Work is performed in a plasma center; exposure to biological fluids, electrical equipment and extreme cold (below 32 °F). Requires protective eyewear, garments, gloves and cold gear. Tasks include sitting for 4‑6 hours/day, standing 2‑4 hours/day, bending, twisting, foot movement, and light lifting up to 15 lb (maximum 50 lb). Hearing acuity and vision (20/30 in one eye, 20/100 in the other) are essential. Work is performed independently with minimal guidance. Pay The estimated pay scale is $20.40–$27.60 per hour; an optional up to 5 % participation in the company bonus pool. Benefits Medical, Dental, Vision, life insurance, PTO, paid holidays, up to 5 % 401(k) match and tuition reimbursement. Location Wood River, IL – 2017 College Ave (Wesley Dr). 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; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. #J-18808-Ljbffr Grifols