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    QA Associate Specialist – Document Control - Seattle, United States - Sunrise Systems Inc

    Sunrise Systems Inc background
    Description

    Job 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.

    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 behaviors 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.


    The hourly rate for this position is between $ $38.00 per hour.

    Compensation:
    Factors that may affect starting pay within this range may include [geography/market, skills, education, experience, and other qualifications of the successful candidate].

    Benefits:
    Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.


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