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Manager, Quality Control - Biomanufacturing Facility

Company: Cedars-Sinai
Location: Los Angeles
Posted on: November 22, 2021

Job Description:

Remember when you said you wanted to make a difference? Here is your chance. Let us connect you with jobs based on your LinkedIn profile. Manager, Quality Control - Biomanufacturing Facility With your help, we can change the future of healthcare! 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. Are you ready to be a part of groundbreaking research? The Quality Control (QC) Manager will provide quality control oversight of clinical manufacturing of final cell products and stage appropriate validation of analytical methods for cell therapy products. As a QC Manager, this role will be responsible for environmental monitoring, raw material testing, in-process and final product testing as well as for the purchase, installation and qualification of QC instrumentation. Additionally, the QC manager is responsible for establishing user requirements for purchase and qualification for analytical equipment, working with internal and external resources to maintain equipment in an optimal state. Review records and issue COAs for product release and develop, revise and review SOPs. Responsible for OOS investigations and participate in deviation investigations. The QC Manager will make certain that manufacturing performs efficiently, coordinate employee efforts when necessary, and facilitate communications between management and production departments. #jobs Primary Job Duties and Responsibilities:

  • Lead and monitor the development of any needed (or future) QC method validation.
  • Oversee and/or perform sterility, endotoxin and mycoplasma testing, cell counts, and viability testing to ensure samples are within the established acceptance criteria.
  • Verify packaging and document the shipment of all outgoing stem cell and related products.
  • Review all QC testing data and related calculations. Maintain all paper and electronic documents and logs associated with QC testing.
  • Issue Certificates of Analysis (CoA) for all outgoing stem cell and related products.
  • Train and qualify laboratory personnel to perform their assigned laboratory duties. Manage inventory and order all supplies needed in QC.
  • Maintain a full understanding of the Standard Operating Procedures (SOPs) and cGMP guidelines, applying them as required. Assist in the development and writing of SOPs, as necessary.
  • Familiarity with 21 CFR Part 210 & 211 procedures.
  • Solve problems by examining and evaluating data, as well as implementing corrective action when necessary.
  • Attend and participate in group and project meetings.
  • Monitor expenditures related to QC activities and programs and assist in budget preparation.
  • Enhance laboratory and organizational effectiveness by accepting responsibility for accomplishing laboratory operational goals and doing so with the highest quality and integrity.
  • Responsible for third-party laboratories executing QC tests for CBC products.
  • In charge of any deviations/investigations that may occur in QC.
  • In charge of OOS investigations; Trending Environmental Monitoring data; Follow USP monographs and be up to date to new analytical techniques.
  • Performs all other duties as assigned. #Jobs-Indeed Educational Requirements:
    • Bachelor degree in Molecular Biology, Biochemistry, Call Biology or related field, required. Experience and Skillset:
      • Five (5) years experience working in a Quality Control capacity, required.
      • Three (3) years experience working as a manager in Quality Control, required.
      • Working Title: Manager, Quality Control - Biomanufacturing Facility
      • Department: CS Biomanufacturing Facility
      • Business Entity: Academic / Research
      • Job Category: Compliance/Quality
      • Job Specialty: Quality Measurement & Reporting
      • 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. Enter your email to refer a friend! Please enter your email address below, and then use the icons to let people know about this great opportunity! Email About the Location Find out what it's like to live and work in Los Angeles, California Explore Top-Rated Workplace We're proud to be the #1 hospital in California on Indeed's Top-Rated Workplaces: Best Hospitals list based on our company reviews. Learn More Specialty Focus: Emergency Department Cedars-Sinai emergency department Learn More Women's Health Research at Cedars-Sinai Cedars-Sinai's research team is making strides in women's health research and treatments. Learn More Join our Talent Network and get Cedars-Sinai news and job alerts delivered to your inbox. First Name Last Name Email Phone Number Current Job Title Years of Experience Upload Resume Interested In Search for a category, location, or category/location pair, select a term from the suggestions, and click "Add". Category Location
        • Compliance/Quality, Los Angeles, California, United States Remove

Keywords: Cedars-Sinai, Los Angeles , Manager, Quality Control - Biomanufacturing Facility, Executive , Los Angeles, California

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