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Senior Quality Control Specialist

United States - California - Santa MonicaQualityRegular

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 Senior Quality Control Specialist, Global Quality Control, to provide Quality Control support to the 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 materials and reagents, within a Good Manufacturing Practices (GMP) environment.

Responsibilities of the Senior Quality Control Specialist include, but are not limited to:

  • Independently performs routine Raw Materials release testing by following established procedures
  • Participates 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/Western Blot, FT-IR, HPLC, LC-MS, PCR, UV and Fluorescence spectroscopy, enzyme assays, microbiological assays 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
  • Provides subject matter expertise and leadership for the investigation and evaluation of non-conformances related to laboratory testing, laboratory OOS investigations, deviations, CAPAs, and change controls
  • Provides data analysis and trending as well as technical solutions to a wide range of difficult problems
  • Leads/coordinates Quality Control and cross-functional projects with limited direction
  • Performs training and cross-training of junior employees; responds to junior employee's issues and requests
  • Assists in writing and delivering year end reviews
  • Assists management with team morale, metric reports, employee development, training, etc.
  • Drives department goals/objectives
  • Authors and revises Standard Operating Procedures
  • Compiles data for trending or investigation purposes; conducts research in regulatory guidance and peer-reviewed journals
  • Performs GMP documentation with attention to detail
  • Gathers documentation; performs data entry 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 4+ years’ experience in biopharmaceutical or pharmaceutical industry OR
  • Bachelor’s Degree and 6+ years’ experience in biopharmaceutical or pharmaceutical industry OR
  • High School Degree and 10+ years’ experience in biopharmaceutical or pharmaceutical industry

Preferred Qualifications:

  • Strong understanding and experience operating within a GMP environment
  • Working knowledge and understanding of analytical techniques to include HPLC, LC-MS, FACS, ELISAs, PCR, 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
  • 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
  • Knowledge of aseptic technique and previous experience with cell culture strongly preferred
  • 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 independently perform duties 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, PowerPoint and other applications
  • Experience using laboratory and quality systems (e.g., Empower)

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