Sr. Quality Control Specialist

Job Description

Senior Quality Control Specialist

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 QC Specialist, 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

• Independently performs 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/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, as assigned.
• Provides data analysis and trending.
• Provides technical solutions to a wide range of difficult problems.
• Leads/coordinates Quality Control and cross-functional projects with limited direction.
• Training and cross-training of junior employees.
• Responds to junior employee's issues and requests.
• Assist in writing and deliver year end reviews.
• Assist management with team morale, metric reports, employee development, training, etc.
• Drive department goals/objectives.
• 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 4+ years’ experience in biopharmaceutical or pharmaceutical industry OR
• Bachelor’s Degree and 6+ 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, 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.
• Preferred, Knowledge of aseptic technique and previous experience with cell culture.
• 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, Power Point and other applications
• Experience using laboratory and quality systems (e.g., Empower)

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