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Sr. Manager Quality Batch Disposition

Company: FPC of Atlanta
Location: Levittown
Posted on: May 16, 2022

Job Description:

Location: Levittown, PA Ready to build the biopharmaceutical Quality Operations processes and support a team that will oversee the development and manufacture of advanced biopharmaceutical products? Ready to learn what end to end capability can look like? Yes? Great Read on and see what else will be involved with as QA Manager of Batch Compliance in this well-funded biopharmaceutical company. Responsibilities include: Provide oversight for On the Floor Quality activities for batch release of raw materials, GMP manufacturing, cell banks, and testing activities. Staff development, mentoring and training. Included here is GMP procedures related to QA batch disposition and release. Review and approve production batch records, specifications, and analytical method validation protocols Lead quality review of manufacturing and laboratory data Failure analysis, risk assessment and mitigation as related to GMP facility qualification Provide QA assistance during internal and external quality audits. Assure batch (both DS and DP) compliance with internal and regulatory standards Provide support of quality systems activities Lead and manage GMP investigations of product specific deviations, OOS, OOT and corrective actions to ensure compliance. Onsite or Remote: Onsite Relocation eligible : Yes, lump sum assistance available Qualifications include: BS or higher degree in scientific or relevant engineering discipline Pharmaceutical Quality Assurance depth required. Sterile or aseptic mfg a plus Depth with raw materials and/or batch disposition / release required. Quality on-thefloor (OTF) Investigations experience Drug development and product lifecycle understanding Ability and desire to build an organization and its capabilities as well as experience in a rapidly growing environments are a plus Familiarity with FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations

Keywords: FPC of Atlanta, Levittown , Sr. Manager Quality Batch Disposition, Executive , Levittown, Pennsylvania

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