QC Specialist I

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.

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission! 

Kite is seeking a highly motivated individual to join Kite as a QC Specialist I, Global Quality Control, to provide Quality Control support of Global Raw Materials and Reagents Center of Excellence (GRM&R CoE).  In this role you will be responsible for the testing, release, and characterization of raw material and reagents, within a Good Manufacturing Practices (GMP) environment. 

Responsibilities 

• Under some guidance and supervision perform routine Raw Materials release testing by following established procedures as written. 

• Participates as needed in the testing of raw materials by following analytical methods compendial methods and/or analytical procedures such as, pH, Osmolality, Conductivity, LAL, Identity, ELISA, Gel Electrophoresis/Western Blot, FT-IR, HPLC, UPLC, UV and Fluorescence spectroscopy, enzyme assays, microbiological assays, bench chemistry methods including titration, colorimetry and other applicable methods for the testing of Raw Materials and Reagents. 

• Maintains instruments, by ensuring calibration and routine maintenance is performed in a timely manner. 

• Leads laboratory OOS investigations, deviations, CAPAs and change controls, as assigned. 

• Authors and revises Standard Operating Procedures. 

• Compile data for trending or investigation purposes or conduct research in regulatory guidance and peer-reviewed journals. 

• Performs GMP documentation with attention to detail. 

• Gathering of documentation and data entry.  

• Documentation and test record review. 

• Keeps laboratory area clean and ensures waste is properly disposed.    

• Keeps laboratory reagent and supply inventory. 

• Supports the department with other duties as assigned. 

Basic Qualifications 

• Master’s Degree and 0+ years’ experience in biopharmaceutical or pharmaceutical industry OR 

• Bachelor’s Degree and 2+ years’ experience in biopharmaceutical or pharmaceutical industry OR 

• Associate’s Degree and 2+ years’ experience in biopharmaceutical or pharmaceutical industry OR 

• High School and 5+ years’ experience in biopharmaceutical or pharmaceutical industry 

Preferred Qualifications 

• Strong