Associate, Regulatory Affairs

ADMA Biologics-posted 3 months ago
Full-time • Entry Level
South Burlington, VT
51-100 employees
Professional, Scientific, and Technical Services
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Responsible for coordinating and executing ADMA Biologics lookback program. Coordinate communications between State, CLIA, and COLA programs with Center Management. Contribute to compliance with FDA's requirements for Biological Product Deviation Reporting.

  • Provide guidance to Plasma Centers regarding compliance with FDA regulations/guidance and applicable international requirements.
  • Coordinate communications necessary to complete government-mandated tasks (e.g., lookbacks, Biological Product Deviation Reports) between Center Managers, other departments, customers, and regulators to facilitate information sharing and resolve problems.
  • Responsible for timely and accurate processing and coordination of ADMA Biologics lookbacks consistent with regulatory requirements and customer specifications.
  • Research discrepant/ missing information and analyze final reports for accuracy to provide accurate and timely information to customers.
  • Serve as ADMA Biologics' primary contact regarding CLIA and COLA programs.
  • Provide guidance and assist in responses to audits and inspections.
  • Evaluate Post Donation (PDI) and Error/Accident Reports (EAR) to determine if they meet the threshold of Biological Product Deviation Reports (BPDR) for reporting to the FDA.
  • Prepare and submit BPDRs to the FDA.
  • Maintain statistical data relating to EARs/PDIs/BPDRs.
  • Evaluate Plasma Center freezer temperature exposure incidents to determine plasma relabeling and reporting to customers.
  • Generate resolution letters for Plasma Center records.
  • Assist with investigations related to DMS change requests, including donor number errors and test hold removals.
  • Track incoming/outgoing paperwork to ensure FIFO processing.
  • Determine what information should be retained versus what should be discarded and prioritize processing.
  • Update departmental SOPs as required.
  • Filing, faxing, copying, and mailing of paperwork and reports.
  • A minimum of 2 years of experience in Plasma or related field or FDA regulated industry with some laboratory and cGMP experience.
  • Bachelor's Degree required. Degree can be offset by equivalent experience.
  • Some general office experience helpful, typing and customer service.
  • Experience in plasma center operations preferred.
  • 401K plan with employer match and immediate vesting
  • Medical, Vision, Life and Dental Insurance
  • Pet Insurance
  • Company paid STD and LTD
  • Company Paid Holidays
  • 3 Weeks' Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-Rail
  • Free shuttle to the Boca Tri-Rail station
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