QA Operations Specialist II

Kite Pharma
El Segundo, CA, United States
Aug 23, 2020
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

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!

We are seeking a highly motivated individual for the role of Quality Assurance Specialist II 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.

  • Provide QA oversight and approval of deviation, OOS, and change control records. Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
  • Provide QA oversight and approval of CAPAs. Ensure CAPAs are initiated and resolved in a timely manner.
  • Ensure escalation of deviations per procedures
  • Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner
  • Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
  • Weekend work and alternate shift may be required

Additional Responsibilities may include:
  • Ensure process control measures are in place and followed in product manufacturing.
  • Review batch-related documentation, and ensure resolution of issues to release product.
  • Support, and as necessary participate in QA on the floor processes, including batch record review.
  • Review and approve manufacturing production records.
  • Generate and update procedures and forms as needed.
  • Perform Product Disposition and Lot Closure.
  • Oversee the packaging and shipping process; authorize shipment.
  • Perform disposition of incoming materials, components, and labels for GMP use.

  • Bachelor's degree in the biological sciences or related field and minimum of 4 years' experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.
  • Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
  • Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Ability to work on multiple records simultaneously and demonstrate organizational, prioritization, and time management skills.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Experience with manufacturing investigations, deviations, and CAPA.
  • Experience with change control practices and strategies.
  • Knowledge of equipment, facility, and utility IQ/OQ/PQ.
  • Proficient in MS Word, Excel, Power Point and other applications

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 Sign up to follow @KitePharma on Twitter at

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.