Job Description
KEDPLASMA is a subsidiary of Kedrion Biopharma Inc. KEDPLASMA specializes in the collection and procurement of high-quality plasma that is processed into plasma-based therapies. Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh-Sensitization. Job Summary Are you detail-oriented and passionate about quality and compliance? Join our team as a Quality Assurance Specialist and help ensure the safety and integrity of life-saving plasma products. In this role, you'll be a key player in upholding regulatory standards and supporting continuous improvement across the center's operations. As a Quality Assurance Specialist, you'll work closely with the Quality Assurance Manager and center leadership to monitor compliance, review documentation, and support training and audit readiness. Your work will directly impact donor safety and product quality. What you'll do Review manufacturing activities and documentation to ensure compliance with SOPs and regulatory requirements. Identify and escalate non-compliance issues that could affect donor safety or plasma quality. Support plasma release and shipment processes, ensuring all units meet specifications. Investigate deviations and assist in implementing corrective actions. Audit records for completeness, consistency, and accuracy to maintain data integrity. Monitor equipment qualification, calibration, and maintenance documentation. Ensure proper storage and documentation of supplies, reagents, and equipment. Perform quality control checks on stored and shipped products, as well as te