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    • QA Associate Specialist - Summit - Omni Inclusive

    Omni Inclusive
    Omni Inclusive Summit

    6 days ago

    Default job background
    Description

    Top Skills:
    - 2+ years of Document Control & Reporting Experience,
    - Veeva experience preferred
    - Technical troubleshooting
    - Self motivated, independent, great communication
    - Experience working cross-functionally

    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.

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