Immunomedics, Inc.

  • GMP Quality Auditor

    Job Locations US
    Posted Date 2 weeks ago(11/28/2018 10:53 AM)
    Job ID
    2018-1375
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    Independently performs quality audits of sterile drug product manufacturers,
    contractors and suppliers that support marketed drug products to ensure
    products, controls, procedures and processes meet quality standards.
    Prepares audit reports and communicates findings to external and internal
    stakeholder. Able to act completely independently as a QA auditor.

    Responsibilities

    • Scope of Authority - span of control (work unit, site, department, division,
      etc.), monetary value of budget/spend authority ( capital, operating, etc.),
      P&L responsibility, etc.
      Audits, across multiple sites, drug product manufacture, suppliers of API,
      excipients, packaging components, and firms providing GMP services such
      as laboratories and others as required.

     

    • Compliance Audits – 80%
      (external)
      Independently conducts external audits, acting as Lead Auditor of an audit
      team, or participating as an external audit team member.
      Provide sterile expertise and experience in auditing
      Able to perform high profile due diligence audit for corporate
      management.
      Schedules audit activities and develop audit agenda.
      Independently performs evaluations of quality systems and practices to
      identify potential problems such as Non-Conformance to applicable SOPs
      and Quality Standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions,
      and provides guidance on quality/compliance risk levels.
      Prepares audit reports and communicates findings to external and internal
      stakeholders.
      Tracks audit responses and auditee’s CAPA until completion and closeout.
    • Regulatory Inspection Support – 5%
      Provides document support for regulatory audits and mock inspections.
      Stays up to date on current FDA and EU sterile manufacturing trends
    • Compliance Department Support – 5%
      Leads and/or supports cGMP projects for continuous improvement to
      ensure compliance with regulations and current industry standards.
      Becomes knowledgeable through experience of Company’s supply chain.
      Act as source of information on all Quality issues with Company’s Supply
      chain vendors.
      Participates in the development of QA programs, policies, procedures and controls.

     

    Qualifications

    • 5-10 years sterile manufacturing experience in either quality or
      manufacturing (supervisory experience desired). 5-10 years Microbiology
      laboratory experience also acceptable.
      ASQ-CQA or ASQ-CQE certified desired.
      Proficiency in a body of information required for the job
      e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing,
      Six-Sigma, etc.
    • Possesses a technical and quality background related to sterile
      pharmaceuticals.
    • Has solid experience and technical expertise in 4 or more audit areas,
      such as API, Micro Lab, Sterile drug product, Contract Pkg., Mock PAI, etc.
    • Has thorough knowledge of current standards and regulations related to
      pharmaceutical dosage forms/devices, (e.g., cGMP, GLP, ICH guidelines
      and guidance documents) and how to apply them to products pending
      release, and marketed products.
    • Demonstrates the ability to review investigations, change control,
      analytical data, test reports, batch records and certificates of analysis and
      other technical documents.
    • Demonstrates the ability to conduct GMP audits of sterile drug product
      and/or medical device manufacturers, as well as manufacturers of chemical
      raw materials and packaging components.
    •  Demonstrates the ability to conduct focused quality incident
      investigations.

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