Quality Assurance Auditor - Paramus - Central Texas Recruiting

    Central Texas Recruiting
    Central Texas Recruiting Paramus

    1 week ago

    $55,000 (USD) per year
    Description
    #Hiring:
    GCP Quality Assurance Auditor


    Location:
    Paramus, NJ


    Pay Rate:
    $55+/hr

    Schedule:
    Contract Hybrid (3 days onsite, 2 days remote)


    The GCP Quality Assurance Auditor will ensure GXP compliance with regulatory authorities, support quality management systems, and conduct internal and external audits in clinical operations, non-clinical, and manufacturing.

    The role supports clinical trials by managing CROs, CMOs, investigator sites, and vendors, providing day-to-day support to the GXP QA Director.

    Key Responsibilities

    Plan and conduct global clinical process and vendor audits across all trials
    Conduct audits based on risk for specific clinical processes
    Perform vendor audits with SMEs (IRT, EDC, etc.) to assess services provided
    Develop and distribute audit reports to stakeholders
    Manage related clinical vendor non-conformances
    Review and audit clinical regulations and guidelines (FDA, GCP, etc.)
    Collaborate with clinical sourcing, supplier quality, and partnerships to manage vendors
    Support regulatory agency inspections preparation and participation
    Participate in quality improvement projects

    Qualifications & Requirements

    BS degree in scientific, healthcare, or related discipline
    5+ years pharmaceutical experience
    2+ years RadioPharmaceutical and QA experience
    Intensive GCP and safety background
    Experience with internal and external audits
    Knowledge of SOPs, QMS, and development policies/procedures
    Ability to work with global teams on audit objectives
    10% travel required

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