Associate, Regulatory Affairs - Boca Raton - ADMA BIOMANUFACTURING LLC

    ADMA BIOMANUFACTURING LLC
    ADMA BIOMANUFACTURING LLC Boca Raton

    19 hours ago

    $65,000 - $115,000 (USD) per year *
    Description

    At ADMA Biologics, we are dedicated to creating superior products for immunodeficient patients at risk for infection. Our commitment to this underserved population drives us and our hands-on approach to production and development sets us apart.

    Associate Regulatory Affairs Role

    This is an exciting opportunity for a dynamic individual with regulatory affairs experience in the biopharmaceutical industry.

    • We are seeking someone who can coordinate communications between State CLIA COLA programs Center Management facilitate information sharing resolve problems provide guidance Plasma Centers compliance FDA regulations applicable international requirements timely accurate processing lookbacks consistent regulatory requirements customer specifications analyze final reports accuracy provide accurate timely information customers serve primary contact regarding CLIA COLA programs evaluate Post Donation Error/Accident Reports determine threshold Biological Product Deviation Reporting prepare submit BPDRs FDA maintain statistical data relating EAR/PDIs/BPDRs generate resolution letters Plasma Center records assist investigations DMS change requests donor number errors test hold removals track incoming outgoing paperwork ensure FIFO processing prioritize processing update departmental SOPs required filing faxing copying mailing paperwork reports
    • Familiarity cGMP procedures high degree attention detail ability understand interpret government regulations customer specifications recognize need appropriate changes relative procedures work high-pressure deadline-driven environment minimum 2 years experience plasma related field laboratory cGMP environment Bachelor Degree preferred offset equivalent experience general office experience helpful typing customer service plasma center operations preferred
    * This salary range is an estimation made by beBee
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