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Regulatory And Audit Compliance Specialist
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$60,000 - $70,000 a year
Full-time
- Founded in 1954, Blood Bank of Delmarva (BBD) is a non-profit, community-based blood center providing blood and blood products to hospitals in the Delmarva region.
- The Regulatory and Audit Compliance Specialist (“Specialist”) is responsible for developing and maintaining a risk-based quality auditing program for the New York Blood Center Enterprise division.
- These include, but are not limited to, activities regulated by the FDA (Food and Drug Administration), AABB (Association for the Advancement of Blood and Biotherapies), (FACT) Foundation for the Accreditation of Cellular Therapy, state departments of health, state laboratories, blood and tissue regulators, and CMS (Center for Medicare and Medicaid Services) / CLIA (Clinical Laboratory Improvement Act).
- Advises on Compliance: The Specialist represents the division as a direct liaison to regulators, managing communications, Biologics License Applications (BLA) submissions, regulatory reporting, and ongoing compliance matters, including the filing of Biological Product Deviation Reports (BPDRs).
- Ensures adequate CAPAs are developed in response to audit findings and monitors CAPA closures.
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