Quality Assurance And Regulatory Compliance Specialist 3
Current-Serve as department QA representative for therapeutic apheresis-Serve as primary Quality contact for local hospital bone marrow transplant programs-Investigate deviations, nonconformances, and CAPAs, and conduct effectiveness checks-Review charts and batch records for release of cellular therapy products-Facilitate audits and inspections by accrediting bodies (AABB and FACT)-Conduct internal and contract laboratory audits for compliance with AABB Cellular Therapy Services and FACT standards,21 CFR 211 GMP, 21 CFR 1271 Good Tissue Practices, 42 CFR 493, PHSA 351 and 361 regulations-Develop and implement GxP training courses for cell therapy lab and apheresis departments-Review and approve equipment validation reports-Perform risk assessments and supplier qualifications-Generate trending reports for cell therapy and apheresis departments
