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    Regulatory Quality Assurance Associate - Bothell, WA, United States - Axelon Services Corporation

    Axelon Services Corporation
    Axelon Services Corporation Bothell, WA, United States

    3 weeks ago

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    Description

    Job Description:
    QualityQA Associate

    This is an Onsite role

    Work Schedule:
    Wednesday - Saturday, 6AM - 4: 30PM EST

    Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews.

    Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits.

    • Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
    • Inspects and releases intermediates or packaged drug product per specifications.
    • Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
    • Drafts and reviews specifications and SOPs.
    • Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
    • May provide guidance to less experienced staff.
    • Provides sitewide support during daily walkthroughs of GMP areas.


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