Supervisor of Quality Control
Department: Quality Control
The Supervisor of Quality Control is responsible for overseeing activities related to the QC testing of Leukocyte Interleukin, Injection (LI) under current Good Manufacturing Practices (cGMP) for clinical application, assay development, analytical methods validation (AMV) and facilities operations and maintenance. Required to travel locally and to an off-site manufacturing and contract facility(s).
The Supervisor of Quality Control reports directly to the Manager of Quality Control.
- B.S. and 7+ years experience with 2+ years supervising (or equivalent experience in related field)
At least five (5) years of experience with at least 1+ years in a supervisory position of a QC laboratory in the Biotechnology, Biopharmaceutical or Pharmaceutical industry working with GMP. Specific experience should include but not be limited to: ELISA testing, Protein assays, gel-electrophoresis, particulate visual inspection, raw materials testing, and general laboratory supervision and maintenance (inventory control, equipment qualification, personnel training). Knowledge and practical experience with HPLC, Endotoxin (LAL), Microbial testing and Analytical Methods Validation (AMV) a plus.
The Supervisor of QC must be a hands-on supervisor and be able to perform the following: QC testing of clinical/commercial Leukocyte Interleukin, Injection (LI)
- Ensure the timely receipt of QC samples
- Ensure the timely testing LI cell culture supernatant, bulk solution, formulated LI drug solution and finished product (per LI Master Batch Record, MBR
- Participate in the testing of LI cell culture supernatant, bulk solution, formulated LI drug solution and finished product, as needed
- Co-ordinate QC testing during formulation of LI drug in contract manufacturer’s facility
- Troubleshoot problems with QC testing assays
- Provide on-site supervision of the LI QC testing activities
- Establish QC trends and develop control charts
Raw Materials (RM) testing and release
- Testing of components, reagents, media, and chemicals, as needed
- Oversee the release of quarantined items
- Trouble shoot problems with raw materials testing
- Review and revise existing QC methodologies in support of raw materials testing
- Identify, evaluate, and meet with contract testing laboratories to discuss new or modify existing testing methods
- Routine maintenance of QC equipment
Position is full time. Weekend, holiday, and evening work to be assigned on a rotating basis, as needed.
Limited local travel to other Company facilities may be required.
We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.
Please submit cv/resume to email@example.com. Reference the job title in the subject line of the email
CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.