Sr. Specialist, Quality Assurance Operations

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Oct 11, 2019
Ref
R0008468
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated individual for the role of Senior Specialist, 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.

Responsibilities:
  • 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.


Qualifications:
  • Bachelor's degree in the biological sciences or related field and minimum of 8 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
  • Must be able 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


#LI-MY1

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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