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    Quality Assurance Associate - Bothell, United States - SSi People

    SSi People
    SSi People Bothell, United States

    2 weeks ago

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    Description

    Quality Assurance Associate

    Join our Team as a Quality Assurance Associate

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

    Job Overview:

    • Maintains quality presence on the shop floor; handles in-process materials and finished products; investigates and resolves any errors; conducts batch record reviews. Ensures that manufactured products meet all regulatory standards. Also, may participate in preparations for regulatory and customer audits.
    • Reviews and approves general and/or complex manufacturing formulation batch production records to support product release as per specifications and SOPs.
    • Inspects and approves intermediates or packaged drug products according to specifications.
    • Monitors different processing stages and associated paperwork to ensure compliance with specifications.
    • Drafts and reviews specifications and SOPs as necessary.
    • Tracks and analyzes batch record errors, providing Quality Assurance management with valuable quality indicator data.
    • Offers guidance to less experienced team members as needed.
    • Conducts regular walkthroughs of GMP areas to provide sitewide support.

    Requirements:

    • Preferably holds a B.S. in Biology, Chemistry, or a related field, or equivalent.
    • Minimum of 2 years of relevant experience in a regulated environment, with at least 2 years focused on product quality.
    • Understanding of biotech product manufacturing processes.
    • Familiarity with US and EU cGMP regulations and guidance.
    • Experience with Oracle, BMRAM, MES, Veeva Infinity is a bonus.


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