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The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease. To learn more about the CBC, please visit: GMP Biomanufacturing Services | Cedars-Sinai (cedars-sinai.org)
The Quality Specialist conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment; and with a team to implement inspection plans, quality plans, support auditing functions, and/or evaluate supplier performance. 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. The Quality Specialist will ensure the quality assurance of clinical manufacturing for quality standards of final cell products and 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. All aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing that appropriate standards of quality are attained and to assure that products are required quality for their intended use.
Primary Duties and Responsibilities:
Assists in the second-level QA subject matter expert/enforcement review of processes in compliance with quality procedures; overall objective of review for investigation
Measures and evaluates supplier quality and delivery performance; maintains supplier quality record files; maintains supplier approval status.
Collects and reviews defect data contained in non-conformance forms, summarized defect data and publishes trend charts and corrective action status and effectiveness
Assists with document control and records management
Serve as SME on the use of risk-based tools for qualification, training, monitoring and disqualification
Assess and approve any changes to cGMP-systems to assure validated state of the systems is maintained
Create and or maintain standardized templates for documents, forms, and similar to provide consistent finished product
Point of contact for Processing Change Orders (CO)
Bachelor's in molecular biology, biochemistry or related science/engineering field, required.
Experience and Skillset:
Three (3) years of experience in Quality or Regulatory compliance, required. Five (5) years of experience, preferred.
Working Title: Quality Assurance Specialist - Biomanufacturing Facility
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 t...eaching 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.