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    Quality Assurance Associate II - Duarte, United States - City of Hope

    City of Hope
    City of Hope Duarte, United States

    4 weeks ago

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    Description

    Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.

    Come join us as a Quality Assurance Associate II where you will be responsible for assisting the QA Manager and Senior QA Associate in achieving compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in the Good Manufacturing Practice (GMP) facilities at City of Hope (COH).

    As a successful candidate, you will:

  • Perform quality assurance for equipment, building, processes, and products to ensure GMP compliance.
  • Review batch records, ensuring proper procedures are used before QA Manager approval.
  • Compile, archive master production, and control batch records.
  • Assist QA Facilities Manager with continuous operation of mechanical systems, monitoring systems, and equipment.
  • Coordinate preventative maintenance and maintain cGMP compliance for building systems and major process equipment.
  • Conduct internal cGMP and safety training for manufacturing staff; provide training to new staff; lead OQS on manufacturing projects.
  • Initiate OOS/CAPA investigations, propose resolutions, and process related forms.
  • Write, review, and process approval of SOPs and quality policies. Handle clean room changeovers, including environmental monitoring, log checks, and equipment calibration. Present project updates and participate in audits. Interact with internal departments and external vendors as directed.
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