QA Associate - Seattle - Synectics

    Synectics
    Synectics Seattle

    6 days ago

    Default job background
    Description
    • Maintains shop floor quality presence, disposition in-process materials and finished product, investigates and resolves Good Distribution Practice (GDP) errors, and performs batch record reviews.
    • Ensures the quality of manufactured products complies with all applicable regulations and guidelines.
    • May assist in preparing for regulatory and customer audits.
    • Reviews and approves general and/or complex manufacturing formulation batch production records in accordance with specifications and Standard Operating Procedures (SOPs).
    • Inspects and releases intermediates or packaged drug product as per specifications.
    • Monitors various stages of processing along with relevant paperwork, ensuring compliance with specifications.
    • Drafts and reviews specifications and SOPs to ensure accuracy and consistency.
    • Identifies and trends batch record errors, providing Quality Assurance management with quality indicator data.
    • Provides guidance and support to less experienced staff members.
    • Conducts sitewide support during daily walkthroughs of Good Manufacturing Practice (GMP) areas.
    Qualifications:
    • Bachelor's degree in Biology, Chemistry, or a related discipline is preferred.
    • Experience in documentation review.
    • Background working in a GMP environment.
    • Candidates out of college with a biology or similar degree who are looking for GMP experience are welcome to apply.
    • At least 2 years of relevant experience in a regulated environment, with at least 2 years focused on product quality.
    • Knowledge of biotech product manufacturing processes.
    • Understanding of US and EU current Good Manufacturing Practice (cGMP) regulations and guidance.
    • Proficiency in Oracle, BMRAM, MES, Veeva Infinity is an asset.


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