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    QA Associate Specialist Document Control - Summit, United States - Aequor Technologies

    Aequor Technologies
    Aequor Technologies Summit, United States

    2 weeks ago

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    Description

    Job Description:

    Top Skills:

    • 2+ years of Document Control & Reporting Experience,
    • Veeva experience preferred
    • Technical troubleshooting
    • Self motivated, independent, great communication
    • Experience working crossfunctionally

    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.


    Duties/Responsibilities:

    Primary responsibilities include:
    " Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.

    " May write and revise document control procedures including participating in the development and roll-out of document control tools.

    " Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.

    " Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.

    " Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.

    " Generate document management system reports for Quality Council metric reporting.

    " Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.

    " Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.

    " Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles

    Position Reports to Jenna Walker

    Associate Director, QA Training & Document Control

    Education:
    Bachelor's degree or equivalent


    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.


    Additional Job Requirements:
    None
    #J-18808-Ljbffr


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