Sr. Specialist QA Operations

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Sep 11, 2019
Ref
R0008465
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Kite is seeking a Senior Specialist of Quality Operations responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. You will be located at our El Segundo, CA site and report into the Associate Director of Quality Operations.

Key Responsibilities (include but are not limited to):

NOTE: Position is Day Shift and rotating weekends.
  • Receipt and disposition of incoming materials.
  • Review batch-related documentation, and ensures resolution of issues to release product.
  • Perform Product Disposition and Lot Closure. Includes commercial and clinical products.
  • Oversee the packaging and shipping process; authorize shipment.
  • Provide QA oversight and approval of deviations. Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines.
  • Provide QA oversight and approval of CAPAs. Ensures that associated CAPAs are initiated and resolved, as needed.
  • Provide QA oversight and approval of change records. Ensures that change records are initiated and resolved, as needed.
  • Support, and as necessary participate in QA on the floor processes, including batch record review.
  • Ensure process control measures are in place and followed in product manufacturing.
  • Maintain metrics related to batch record review and product disposition in support of the Management Review.
  • Generate and update procedures and forms as needed.


Qualifications:
  • Bachelor's degree in the biological sciences or related field and minimum of 7 years progressive 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
  • Ability to effectively negotiate and build collaboration amongst individuals
  • Good interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities


#LI-ZN1

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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