Manager, Quality Control - Biomanufacturing Facility
Location: Los Angeles
Posted on: November 22, 2021
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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
- 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
- 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
- In charge of any deviations/investigations that may occur in
- In charge of OOS investigations; Trending Environmental
Monitoring data; Follow USP monographs and be up to date to new
- Performs all other duties as assigned. #Jobs-Indeed Educational
- Bachelor degree in Molecular Biology, Biochemistry, Call
Biology or related field, required. Experience and Skillset:
- Five (5) years experience working in a Quality Control
- Three (3) years experience working as a manager in Quality
- Working Title: Manager, Quality Control - Biomanufacturing
- 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.
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