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    • Quality Assurance Document Control - Bothell - Omni Inclusive

    Omni Inclusive
    Omni Inclusive Bothell

    3 weeks ago

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    Description

    Job Summary

    We are seeking a highly skilled Quality Assurance Document Control (QADC) Associate Specialist to support the cGMP Document Control operations for our client site. The successful candidate will be responsible for managing document change control, issuing and reconciling batch records, and ensuring adherence to GMP regulations.

    Key Responsibilities

    • Document Control: Issue production batch records, labels, and other controlled documents to support manufacturing operations
    • Document Organization: Organize cGXP controlled document files within the Document Center and ensure that records are readily retrievable
    • Electronic Document System Management: Review and approve document change requests, troubleshoot, and release documents to an effective state
    • Procedure Development: Write and revise document control procedures, including participating in the development and roll-out of document control tools
    • Audit Support: Assist with internal and external audits and regulatory inspections, including data gathering, interviewing, and escorting auditors
    • Metric Reporting: Perform Document Control metric reporting and analysis for local site data

    Requirements

    • Education: Bachelor's degree or equivalent
    • Experience: Minimum 1 year of relevant document control management experience in a cGMP/FDA regulated environment
    • Skills: Strong communication and customer service skills, technical writing skills, and proficiency in MS Office and Quality Systems

    Working Conditions

    Employees holding this position will be required to perform job-related duties supporting Manufacturing Operations, related to batch documentation to support various Manufacturing shifts. Weekend and off-shift support may be required.

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