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  • QA Specialist - Seattle - ASK Consulting LLC

    ASK Consulting LLC
    ASK Consulting LLC Seattle

    4 weeks ago

    Default job background
    Description

    Job Title: QA Specialist

    A critical role within our Vector CMO Quality Assurance team is available for a highly skilled and detail-oriented QA Specialist. In this individual contributor position, you will be responsible for reviewing cGMP Controlled Documents, approving batch records, and managing the implementation of required changes to meet cGMP and internal standards.

    Key Responsibilities:

    • Review and approve deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).
    • Oversee and review CMO batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with supply chain, warehouse, and quality control departments.
    • Support the vector disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.

    Requirements:

    • 4-7 years of relevant cGMP experience.
    • Hands-on experience with material introduction and disposition is preferred.
    • Knowledge of cGMP regulations and FDA, EU, ICH guidance applicable to biologics and cell therapy manufacturing/quality control.
    • Strong computer skills with Word and Excel and other electronic manufacturing systems.
    • Detail oriented team player with effective planning, organization, and execution skills.

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