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15 days old

QC Manager

Kelly Services
Duarte, CA 91009
**We are Kelly Science and Clinical,** the second d largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with an established (over 100-year-old) remarkable, non-profit National leader and Cancer Institute-designated comprehensive cancer center and founding member of the National Comprehensive Cancer Network. This organization is advancing Cancer Research, Clinical Research, and treatment protocols for chronic life-threatening diseases such as Cancer, Diabetes and HIV/AIDS.


**Position Title: Quality Control Manager (Biologics)**


**Overview**


Our client is an innovative biomedical research, treatment, and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy. The QC Manager will effectively manage the QC team by providing technical training and supervision, prioritizing assigned tasks, and reviewing and approving testing results; meeting the expected deadlines is a critical part of the position. **Responsibilities may include (but are not limited to) the following:**


+ Recruits, manages, and provides technical training to QC staff to perform tasks in cGMP facility.

+ Oversees quality control activities for products to ensure compliance with Good Manufacturing Practices (GMP) for the Biologics and Cellular GMP Facilities.

+ Establishes and performs all necessary in-house assays to release products, including viral vectors, plasmid DNA, antibodies, recombinant proteins, and cellular products.

+ Reviews and revises standard operating procedures as necessary. Assists in the preparation of new standard operating procedures as directed by supervisor(s).

+ Reviews and approves assays performed by 3rd parties and ensures quality of service.

+ Develops necessary assays for product release and process monitoring.

+ Reviews and signs off on QC batch records and assures that the proper procedures and processes have been used in the release testing of products and raw materials.

+ Shares responsibility with the QA Officer for preparedness for inspections by regulatory agencies so that there is a positive outcome and a minimum disruption in the daily operation and ensures that agency inspectors are provided with all necessary information. Assists in the preparation of responses to recommendations of other regulatory requirements.

+ Reviews all completed QC release test reports and other QC related reports that are generated. Review and approve Certificate of Analyses (CoA).


**Education/Experience Requirements:**


+ Legally authorized to work in the job posting Country.

+ Masters Degree with coursework in Biochemistry, molecular biology or life science related with ten (10) years of biologics with cell-based assays, QC/Research experience in Biologics manufacturing. and familiarity with analytical methods employed in modern cell biology, molecular biology, and virology laboratories, including Q-PCR, capillary electrophoresis, FACS, ELISA, infectious titer assay, etc.

+ **OR** PhD in Biochemistry, molecular biology, or life science related field with (5) years of biologics industry experience as described above.

+ Supervisory experience is required, preferably in an industrial setting. **Our Client Offers a Generous Compensation & Benefits Package EOE, including Disability/Vets**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-31 Expires: 2021-07-01

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QC Manager

Kelly Services
Duarte, CA 91009

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