QA Associate III - Cell Therapy Manufacturing
About The Position
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. A Quality Assurance Associate III is available in the Beckman Research Institute of City of Hope. You will be responsible for assisting QA Management 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 GMP facilities at City of Hope (COH). As a successful candidate, you will:
Requirements
- Bachelor’s degree with 6-8 years of experience within Quality Assurance required.
Nice To Haves
- Masters degree preferred with 6+ years of experience or PhD with 1+ years of experience or Bachelors degree with 10+ years of experience preferred.
Responsibilities
- Perform quality assurance activities in the QA Compliance function and ensure compliance with Good Manufacturing Practices (GMP).
- Administer the Deviation, CAPA, and Change Control programs as Business Process Owner.
- Author Deviations in collaboration with originating departments and SMEs.
- Track, Trend, and monitor the progress of Deviation, CAPA, and Change Controls in alignment with SOP criteria, assigned due dates, and business timelines.
- Provide and evaluate Quality System KPI data in support of Quality Management Review
- Schedule and coordinate the Change Control Committee meetings
- Conduct internal cGMP training. Maintain training records and the training program.
- Coordinate and conduct Internal audits, follow up and write reports for submission to QA management. Track and follow up on audit commitments for timely completion and closure.
- Coordinate and conduct Supplier Quality Assessments and maintain the Approved Supplier List. Perform Supplier requalification in alignment with SOP criteria.
- Write reviews and process Standard Operating Procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
