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Bothell

    QA Analyst - Bothell, United States - TechData Service Company LLC

    TechData Service Company LLC
    TechData Service Company LLC Bothell, United States

    3 weeks ago

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    Description

    Job Description

    Job Description

    Quality Assurance Associate - Local and W2 candidates only

    Location: Bothell, WA

    Duration: 12+ Months

    Job Schedule: Wednesday - Saturday, 6AM - 4:30PM PST

    Responsibilities:

    • Maintains shop floor quality presence by handling in-process materials and finished products
    • Investigates and resolves GDP errors
    • Performs batch record reviews
    • Ensures manufactured products comply with regulations and guidelines
    • Assists in preparing for regulatory and customer audits

    Main Responsibilities:

    • Performs manufacturing formulation batch production record reviews and approval
    • Inspects and releases intermediates or packaged drug products
    • Monitors processing stages and paperwork
    • Drafts and reviews specifications and SOPs
    • Monitors batch record errors and provides quality data
    • May mentor junior staff
    • Supports daily walkthroughs of GMP areas

    Requirements:

    • Bachelor's degree in Biology, Chemistry, or related field preferred
    • Minimum 2 years of experience in a regulated environment focusing on product quality
    • Knowledge of biotech product manufacturing
    • Familiarity with US and EU cGMP regulations
    • Experience with Oracle, BMRAM, MES, Veeva Infinity a plus

    TechData is an equal opportunity employer dedicated to diversity and inclusion in the workplace. We welcome applicants from all backgrounds.


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