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San Rafael

    Quality Document Control Specialist - San Rafael, United States - Bayside Solutions

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    Description
    Quality Document Control Specialist
    W2 Contract

    Salary Range:
    $58,800 - $69,200 per year

    Location:
    Novato, CA - Hybrid Role

    Job Summary:


    The QA Documentation Control Specialist II is responsible for maintaining the cGMP-controlled documentation system and providing the various departments with the documentation necessary to perform cGMP activities.

    Responsibilities include auditing existing documentation, reporting document trends to management, and managing electronic document systems.


    Duties and Responsibilities:
    Process requests for document changes utilizing the EDMS
    Process document special handling requests
    Provide department metrics to management
    Participate in documentation audits
    Process logbook requests and perform routine audits
    Process laboratory notebook requests
    Responsible for maintaining the Archive Room, including filing and assisting customers
    Identify improvements with group-level impact
    Manage assigned work and take on additional responsibilities
    Involved with other projects as required


    Requirements and Qualifications:
    BA or BS in a related discipline
    Experience in auditing documentation
    Proficiency in Microsoft Word and Excel; Livelink and Microsoft Access experience is a plus.
    Able to communicate clearly and effectively through verbal and type-written correspondence; easily legible penmanship
    Strong organizational skills to coordinate multi-discipline projects
    Experience in participation in regulatory inspections is a plus
    Understanding and familiarity with FDA and European regulatory requirements and guidelines

    Desired Skills and Experience
    Quality Document Control, EDMS, Word, Excel, Livelink, Access, regulatory

    Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at

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