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    Document Control Specialist - Bothell, United States - SSi People

    SSi People
    SSi People Bothell, United States

    1 month ago

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    Description

    Role: Quality Assurance Document Control

    Location: Bothell, WA

    Contract: 6 Months

    Shift- Sunday - Thursday 10:00pm - 6:30am

    Top Skills:

    • communication and customer service skills.
    • to prioritize, manage time well, multi-task, and troubleshoot effectively.
    • and Excel experience
    • to provide examples on how they have honed in on attention to detail
    • of SOPs, procedures, edits, and annotations within EDMS experience

    Duties And Responsibilities:

    • production batch records, labels, and other controlled documents to support manufacturing operations.
    • for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
    • with managing the Document Center Archive room.
    • an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
    • write and revise document control procedures including participating in the development and roll-out of document control tools.
    • Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.

    REQUIRED COMPETENCIES: Knowledge, Skills, And Abilities:

    • of 1 year of relevant document control management experience in a cGMP/FDA regulated environment.
    • communication and customer service skills.
    • technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles.
    • computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
    • demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.

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