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QA ASSOCIATE III - CELL THERAPY MANUFACTURING - 10033790
Duarte, CACity of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases.
Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional cancer expertise.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
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:
· 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.
Your qualifications should include:
· Bachelor’s degree with 6-8 years of experience within Quality Assurance required.
· Masters degree preferred with 6 years of experience or PhD with 1 years of experience or Bachelors degree with 10 years of experience preferred.
City of Hope is an equal opportunity employer.
To learn more about our Comprehensive Benefits, please CLICK HERE.