QC Specialist I

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 understanding and experience operating within an GMP environment.

• Working knowledge and understanding of analytical techniques to include HPLC, ELISAs, FTIR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents within an GMP environment.

• Working knowledge using bench chemistry methods such as titration and colorimetry.

• Basic understanding of handling hazardous waste.

• Strong experience leading OOS’s, CAPAs, change controls, deviations and laboratory investigations.

• Knowledge of current Good Manufacturing Practices (cGMPs), GxP, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry.

• Exceptional attention to detail and ability to keep track of multiple ongoing projects

• Experience writing, reviewing, or executing standard operating procedures, protocols, and reports.

• Ability to perform duties with minimal supervision and be adaptable to a dynamic and fast-paced environment

• Excellent interpersonal and organizational skills

• Strong project and time management skills.

• Excellent oral and written communication skills

• Proficiency in MS Word, Excel, Power Point and other applications