In the Cedars-Sinai Biomanufacturing Center (CBC), o ur mission is to accelerate scientific discovery by generating world-class biomaterials and conducting groundbreaking research in biobanking, personalized medicine and stem cell biology. For more information on the CBC, please visit https://www.cedars-sinai.org/research/areas/biomanufacturing.html .
As a Quality Assurance Lead in the CBC, you will conduct complex work under minimal supervision and with wide latitude for independent judgement. This role oversees a team to implement inspection plans, quality plans, support auditing functions, and/or evaluate supplier performance.
Additional Job Duties and Responsibilities:
Contributes to the planning, implementation, and administration of cost-effective Quality Programs, assuring that a system is in place which will meet contractual quality requirements.
Responsible for overseeing quality assurance of clinical manufacturing for quality standards of final cell products.
Identifies and assesses quality risk in activities and processes per regulatory guidelines, cGMPS, and standard operating procedures.
Responsible for ensuring 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 cGMP facilities of the CBC.
Responsible for all aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing.
Ensures that appropriate standards of quality are attained and that products are required quality for their intended use.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research... and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.