Senior Quality Control Specialist

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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