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    Quality Document Control Specialist - Novato, United States - Intelliswift

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    Description
    Onsite with Hybrid option after training

    The QA Documentation Control Specialist II is responsible for the maintenance of the cGMP controlled documentation system and for providing the various *** departments the documentation that is necessary to perform cGxP activities.

    Other responsibilities include auditing existing documentation, reporting document trends to management, and managing electronic document systems.
    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 Archive Room:
    filing, assisting customers
    Identifies improvements with group-level impact
    Manages assigned work and takes on additional responsibilities
    Involved with other projects as required

    Preferred experience in auditing documentation
    Proficiency in MS Word & MS Excel. Livelink and MS Access a plus
    Ability to communicate clearly and effectively through verbal and type-written correspondence
    Legible penmanshipOrganizational skills to coordinate multi-discipline projects
    Experience in participation in regulatory inspections a plus
    Understanding and familiarity with FDA and European regulatory requirements, guidelines
    #J-18808-Ljbffr


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