QC Specialist III

Kite Pharma•El Segundo, CA

3d•Onsite

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. This position is for Sun-Wed Swing Shift, 12:00PM to 10:30PM.

Requirements

5+ years of relevant experience and a BS or BA.
3+ years of relevant experience and a MS.
Prior experience in pharmaceutical industry is preferred.

Responsibilities

Lead (or support) projects in Analytical Method development, validation, and method technology transfer in areas of Flow Cytometry, ddPCR and Bioassays consisting of cell culture and ELISA.
Lead (or support) studies, implementation of new processes or technologies, and revise or review SOPs, qualification/validation protocols and reports.
Perform analytical assays in techniques such as Flow cytometry, ddPCR, cell culture and ELISA GMP environment.
Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
Support audit activities and regulatory inspections by assisting in preparation of dossiers and data packages for interactions between Kite and Regulatory agencies, if needed.
Review proposed changes to systems, procedures, methods and submissions to regulatory agencies, as appropriate.
Lead investigations regarding out of specification (OOS) results, Out of Trend (OOT) events and any other unexpected event related to the laboratory.
Support generation of trending charts for monitoring method performance, product quality, invalid rate and/or stability.
Perform QC sample receipt, processing, and distribution for testing and storage as well as track inventory of lab supplies and materials.
Monitor the GMP systems currently in place to ensure compliance with documented policies.
Support generation of CoAs for product release as needed.
Mentor and support on the job training for junior staff.