QA Operations Specialist I

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!

We are seeking a highly motivated individual for the role of Specialist I, QA Operations to work in this exciting new area of cancer immunotherapy. You will report into the Quality Records Team Manager of QA Operations and be based in our El Segundo site and associated clinical and commercial manufacturing and testing laboratories.

Key Responsibilities include (but are not limited to):

• Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
• Provide Quality Assurance support involving manufacturing production issues
• Ensure that Kite products are manufactured in compliance with site, regulatory and GMP guidelines
• Ensure timely issuance of production records and labels
• Elevate issues affecting lot production or release to Management in a timely manner
• Ensure approval and timely delivery of Final Product
• Review and approve executed Manufacturing Production Records for Regulatory and Kite compliance
• 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, as needed
• Gather metric information for use in continuous improvement of areas of responsibility, as needed
• Perform other duties as required to fulfill department and business needs
• Work schedule is Tuesday - Saturday, and holidays as needed.

Qualifications/Skills:

• Bachelor's degree in a technical discipline (Biology/Chemistry/ Microbiology/ Engineering or related field) and 2+ years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
• Working knowledge of GMP, quality systems and regulatory requirements (21 CRF Part 11/210/211/600/610), practices/principles
• Knowledge of relevant ICH and FDA guidance documents
• Experience in identifying deviations and CAPA
• General knowledge of aseptic manufacturing processes
• 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
• Experience with cell therapy manufacturing
• ASQ certification(s)
• Experience with internal and external audit
• Experience with Health Authority Regulations and Validation practices/principles
• Knowledge of IQ/OQ/PQ

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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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