The Cedars-Sinai Biomanufacturing Center (CBC) is a new cell manufacturing facility with world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, which will provide a much-needed biomanufacturing center in Southern California. As dedicated partners in biomanufacturing, we strive to provide the highest levels of quality and safety of the manufactured products through robust and effective quality systems, process controls, rigorous performance criteria and testing.
As a QA Manager, you will provide quality assurance oversight of clinical manufacturing of final cell products and identify and assess quality risk in activities and processes per regulatory guidelines and standard operating procedures. You are 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.
Job Duties and Responsibilities:
Provides validation support for all equipment and processes and approves all outcomes, which are essential to the production of GMP manufactured products.
Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate.
Oversees the documentation of processes and maintenance of records.
Manages the regulatory inspections and auditing, comparing actual conditions to requirements and report to management
Ensures that all aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing attain appropriate standards of quality and assures 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.