QA Associate Specialist – Document Control - Summit, United States - TSR Consulting Services, Inc.

    TSR Consulting Services, Inc.
    TSR Consulting Services, Inc. Summit, United States

    3 weeks ago

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    Description

    TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

    Our client, a leading pharmaceutical company is hiring a QA Associate Specialist – Document Control on a contract basis. Please only local candidates to Summit NJ.

    Work Location: Summit NJ

    Pay: $30-31/hour W2

    Required Skills:


    • Document Control & Reporting experience


    • Veeva experience preferred


    • Technical troubleshooting


    • The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP

    Document Control operations for Cell Therapy organization


    • Managing an electronic document system which includes reviewing and approving document

    change requests, troubleshooting and releasing documents to an effective state


    • May write and revise document control procedures including participating in the

    development and roll-out of document control tools


    • Follow Policies, SOPs, and work instructions to support the document approval process,

    assign effective dates and training workflows, and archive documents and document change

    requests


    • Assist with cross-training of Document Control personnel and customers to ensure adherence

    with procedures


    • Execute the process and procedures for identifying, collecting, distributing and filing the

    controlled documents for the site


    • Generate document management system reports for Quality Council metric reporting


    • Support internal and external audits and regulatory inspections if required


    • Assist with document retrieval /organization support during regulatory inspections


    • Provide communication as to the status of Quality Systems deliverables to customers,

    management, and stakeholders


    • Some technical writing skill set and be able to critically review documents while effectively

    inputting and expressing Quality principles


    • Relevant document control experience in a cGMP/FDA regulated environment


    • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality

    Systems (e.g. Document Management System, Quality Management System)


    • Experience interacting with FDA or other regulatory agencies strongly preferred


    • Strong knowledge of cGMPs and domestic regulatory requirements


    • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems,

    validation, etc.)