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    QA Associate Specialist Document Control - Summit, United States - Sunrise Systems

    Sunrise Systems
    Sunrise Systems Summit, United States

    2 weeks ago

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    Description

    Top Skills:

    • 2+ years of Document Control & Reporting Experience,
    • Veeva experience preferred
    • Technical troubleshooting
    • Self motivated, independent, great communication
    • Experience working cross-functionally

    Position Summary:

    The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.

    Education:
    Bachelors degree or equivalent

    Experience Basic Qualifications:

    • Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
    • Strong communication and customer service skills.
    • Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
    • 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)
    • Must demonstrate the following behaviours consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
    • Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
    • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
    • Possess project management skills.
    • 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.).
    • Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.


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