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Thousand Oaks

    Quality Assurance/Manufacturing Batch Record Reviewer - Thousand Oaks, United States - Aequor

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    Description

    Job Title: MCS Senior Quality Assurance Associate

    Location: Thousand Oaks, CA

    Shift: Day & Swing Shift

    Terms: Contract W2

    Description:

    Fully onsite at the Thousand Oaks facility, not remote

    6 months contract with possible extension based on performance

    M- F 7am-4pm / 10am-7pm swing shift. Must commit to swing shift with a 10% differential. Shift flexibility required based on production schedule

    Ideal candidate: Will be involved in tasks on the manufacturing floor.

    Detail-oriented, team player, and quality experienced individual.

    The Senior Associate Quality Assurance position supports the Quality Assurance program within the Plant QA organization, providing daily oversight of Drug Product manufacturing areas. With general supervision, this role offers support and compliance oversight to Manufacturing, Facilities, and Engineering staff in their processes, procedures, and utilization of quality systems.

    Duties include, but not limited to:

    • Purposeful presence on the manufacturing floor, including Inspection support, ASP, and QA assessments
    • Electronic batch record review
    • SOP revision approval
    • Maximo System - Work order and job plan approvals
    • Quality support and approval of minor deviations and CAPA records
    • MES revisions and approvals

    Responsibilities also involve evaluating compliance issues, providing recommendations, and ensuring the progress of quality records to completion. The Senior Associate will represent the functional area quality for the Drug Product Quality Assurance department in project executions to achieve operational goals and will collaborate in a team matrix environment.



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