Senior Quality Assurance Specialist

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients.

We are seeking a highly motivated individual to join us as Senior Quality Assurance Specialist to provide Quality Assurance oversight of Clinical Manufacturing, Materials Management, and Quality Control areas in our new research and clinical production facility located in Gaithersburg, Maryland. This facility will focus on the new challenging field of fully personalized T cell neoantigen reactive therapy for solid tumors using individual patient neoantigen TCRs. Must be proficient in Quality Systems, particularly associated with Operations, Lot Disposition, Change Control and Exception Management / CAPA.

Responsibilities (include but are not limited to):

• Work with the Clinical Manufacturing, Materials Management, & Quality Control departments as a Quality Assurance representative
• Coordinate and facilitate Quality Assurance related production and production related activities
  • Ensure timely issuance of production records, procedures and labels
  • Ensure timely assessment and closure of discrepancies, Deviations and Change Controls requests
  • Ensure timely assessment and closure of Laboratory Investigations
  • Ensure timely assessment and closure of batch and material hold events
  • Communicate lot disposition pending issues to Management
  • Ensure approval and timely delivery of Final Product
• Ensure that tests are performed and products are manufactured in compliance with regulatory and GMP guidelines
  • Manage and perform area Person in the Plant activities
  • Review and approve Manufacturing and Validation documents for Regulatory and Kite compliance
  • Review and approve Test Methods and Qualification/Validation protocols and reports
  • Review and approve Manufacturing Production Records
  • Compile and verify all batch related documents into a Final Product lot disposition package
• Perform quality investigations of manufacturing Deviations, GMP and Quality System issues, non-conforming materials, and CAPA
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
  • Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities
  • Provide periodic updates to Management for Deviations, GMP and system issues, non-conforming materials and products and CAPA

• Review and disposition disposable raw materials and components for GMP use
• Review equipment and facility technical and investigation reports
• Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
• Gather metric information for use in continuous improvement of areas of responsibility
• Mentor junior staff
• Perform other duties as required

Requirements:

• Bachelor's degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 8 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
• Working knowledge of various ASQ Bodies of Knowledge
  • Black Belt/Green Belt certifications a plus
• Strong knowledge of GMP, SOPs and quality systems
• Experience with approving test method qualification/validation protocols and reports
• Identifying, writing evaluating and closing Deviations and CAPA
• Experience with internal and external audit principals
• General knowledge of aseptic manufacturing processes
• Experience with Change Control practices/strategies
• Knowledge of laboratory and production equipment IQ/OQ/PQ
• Proficient in MS Word, Excel, Power Point and other applications
• Strong written and verbal communication skills
• Ability to communicate and work independently with scientific/technical personnel

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IND123

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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