Quality Assurance Coordinator

Job Description The Quality Assurance Coordinator works under the supervision of the Quality Assurance Manager and may receive instruction and tasks from the Center Manager and Director of Quality Assurance. The Coordinator ensures product integrity and the continued good health of donors by complying with Food and Drug Administration (FDA) regulations, state regulations, the company’s Standard Operating Procedure Manual, and other applicable regulatory standards. Schedule & Training: Availability required Monday–Friday and every other Saturday (3 on, 4 off). Five weeks of paid training (Monday–Friday). Job Type: Full‑time Essential Duties and Responsibilities Organize product in storage freezer, ensuring complete and consistent organization. Perform QA review of product to be shipped to the consignee. Set up, operate, and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control); manage supply and determine release in FIFO process. Maintain instruments/equipment used for processing and/or qualifying and storage of donor samples and products; ensure instruments function properly and are cleaned. Document operational and maintenance activities when necessary. Assist the Quality Assurance Manager in ensuring all center operations, product storage, documentation, facility maintenance, quality control, and training comply with the company’s SOP and current State/Federal guidelines, OSHA, CLIA, cGMP, and internal procedures. Oversee and perform destruction of unsuitable units; quarantine and discard unacceptable samples and products. Oversee release and shipment of biohazardous waste. Perform internal audits and quality checks on‑site. Assist Management with employee training and counseling as needed. Oversee receipt of center inventory, including donation soft‑good supplies and QC reagents. Manage lot‑controlled supplies, ensuring appropriate storage and use per SOP; approve and release new supply lots as needed and ensure availability. Oversee daily management of samples to the testing lab; pack and ship samples to the testing lab. Assist with final QA review and release for all product shipments and associated documents, ensuring shipments meet customer specifications and product quality. Assist in shipment of product from the center; complete and review shipment paperwork for each shipment. Report to the Quality Manager any deviations or quality concerns observed at the center. Assist with qualifying and reviewing equipment. Available to travel up to 25 miles to other facilities for training or to assist other centers’ staffing needs. Perform other duties as assigned. Education High School Diploma, required; Associate’s or Bachelor’s degree preferred in Management, Business, Nursing, Finance, or a science‑related field. Skills and Qualifications Excellent verbal and written communication skills. Excellent interpersonal and customer service skills. Excellent organizational skills and attention to detail. Consultation. Ethical practice. Cultural awareness. Business acumen. Relationship management. Strong computer skills; familiarity with Microsoft Office applications. Physical Requirements Read computer screens, procedure manuals and other documents. Hear doorbells, alarms, telephone, and other mechanical devices. Work confidently while being observed during frequent quality inspections. Work in walk‑in Subzero freezer(s). Ability to lift, pull, tug up to 50 pounds to stock supplies and/or move or support donors. Regularly required to use hands and fingers, handle & feel objects, tools and controls; reach with hands and arms. Vision abilities required, including close vision. Required to stand for extended intervals, walk, climb, balance; stoop, kneel and crouch. Physical ability to operate equipment that may require repetitive motion and manual dexterity. Ability to read while standing or sitting in front of a computer for extended periods (2–3 hours). Must wear personal protective equipment (PPE) such as eyewear, lab coats, and gloves. Benefits Competitive wages Flexible scheduling Positive work environment Paid training opportunities Comprehensive medical and dental benefits Paid time off 401(k) #J-18808-Ljbffr