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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 Home – CSBIO (csbiomfg.com).
Are you ready to be a part of groundbreaking research?
The Quality Assurance (QA) Manager provides quality assurance oversight of clinical manufacturing of final cell products and identifies and assesses quality risk in activities and processes per regulatory guidelines 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 CBC. Provides validation support for all equipment and processes; and approves all outcomes, which are essential to the production of biological products. Oversees the documentation of processes and maintenance of records. Leads the construction of a validation master plan for the CBC during the construction phase. All aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing to ensure that appropriate standards of quality are attained and to assure that products are required quality for their intended use.
Primary Job Duties and Responsibilities:
Education:
Licenses and Certifications:
Experience and Skills:
Working Title:
Quality Assurance Manager – Biomanufacturing Center
Department:
CS Biomanufacturing Facility
Business Entity:
Academic / Research
Job Category:
,Academic/Research,Academic/Research
Job Specialty:
Research Studies/Clinical Trials
Position Type:
Full-time
Shift Length:
8 hour shift
Shift Type:
Day
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.
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