
Senior Quality Control Specialist
United States - California - Santa MonicaQualityRegularJob 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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