Supervisor, Quality Control Sample Management
Quality | El Segundo, CA | Full Time
Kite is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term, durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. For more information on Kite, please visit www.kitepharma.com.
We are seeking a highly motivated individual to join us as a QC Sample Management Supervisor in our new commercial cell therapy production center located in El Segundo CA. You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. In this role you will be responsible for the day to day oversight of the QC Sample Management team spanning across 7 days and 2 shifts.
Responsibilities (include but are not limited to):
- Supervision of sample receipt, retain storage and disposal
- Management of QC Sample Management training program
- Management of Stability samples, including managing the schedule and pulling samples for QC testing
- Monitor and trend data related to samples
- Complete routine record review
- Develop, revise and review SOPs, and reports
- Conduct investigations related to sample management deviations
- Provide updates to Manager
- Monitor the GMP systems currently in place to ensure compliance with Kite policies and procedures
- Other duties as assigned
- Bachelor's degree in Biology or related discipline
- Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
- A minimum of 5 years’ experience working in sample management in a regulated business (Clinical test labs or Pharmaceutical GMP environment). A minimum of 1 year experience supervising/managing a Sample Management group/lab
- The ideal candidate is well versed in sample chain of custody, general lab procedures such as operating centrifuges, working within a Biological Safety Cabinet and experience with inventory management systems such as Freezer Works or LIMS
- The incumbent will need to have the ability to work in a laboratory setting and lift up to 25 lbs.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) related to sample management/retention requirements
- Strong knowledge of cGMPs and quality control processes
- Strong data integrity knowledge and practices.
- Proficient in MS Word, Excel, Power Point and other applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Job requires some overtime and weekend work as needed
Kite Pharma is an equal opportunity employer based in beautiful Santa Monica, CA. Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com
No phone calls please and no agencies or recruiter