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    Quality Assurance Supervisor - New York, United States - Hartmann Young

    Hartmann Young
    Hartmann Young New York, United States

    3 weeks ago

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    Description


    Our client's Quality Assurance group is actively searching for a driven individual to join their expanding team as a QA Supervisor within the QA Compliance Group.

    This role focuses on ensuring adherence to regulatory requirements, company policies, and procedures.

    The chosen candidate will aid in regulatory filings, engage in regulatory/client audits, and supervise aspects such as supplier quality, document management, Change Management, and overall Quality Management Systems.

    Additionally, they will undergo cross-training in various areas of Quality Assurance.


    Responsibility:
    Ensuring that the QMS system aligns with regulatory standards.
    Leveraging electronic quality management systems to enhance compliance tracking, trend analysis, and issue resolution.
    Executing both internal and external audit initiatives.
    Overseeing regulatory audits, encompassing FDA, EMA, and other pertinent health agencies.
    Supervising Change Controls, Document Control Quality Metrics, and supplier quality.
    Providing support for quarterly management review (QMR) processes.
    Establishing, executing, and overseeing an inspection readiness program.
    Advocating for the Quality Risk Management program.
    Managing Quality Metrics to ensure adherence to standards.
    Conducting cross-training with the Supervisor of QA Operations and Supervisor of Investigations and CAPAs.
    Reviewing and sanctioning change controls and other GMP documents as appropriate.
    Directing the Suppliers and Vendors Audit Program.


    Requirements:
    A bachelor's, master's, or Ph.
    D. degree in biology, biochemistry, biotechnology, chemistry, or a related field is essential.
    Minimum of five years of experience in cGMP concerning biological products and cell cultures.
    Comprehensive expertise in the field coupled with proven leadership abilities.
    Previous experience in a supervisory role is mandatory.

    If this opportunity is of interest please reach out to me on
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