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Quality Assurance Operations Specialist - $8,000* Sign On

United States - California - El SegundoQualityRegular

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.

We are seeking a highly motivated QA Operations Specialist I for our commercial facility in El Segundo, CA site.

Shift schedule: (Graveyard Shift) 12:00 AM – 10:30 AM.  Typical schedule is Wednesday through Saturday.


  • Perform receipt and disposition of incoming apheresis and frozen PBMC
  • Perform verification of final product labels
  • Perform shipment authorization
  • Perform incoming label inspection
  • Perform disposition of incoming labeling materials, as assigned
  • Review batch-related documentation, and ensure resolution of issues to release and ship product
  • Support and participate in timely resolution and escalation of accession related activity issues
  • Initiate, investigate and resolve all product related deviations, as assigned
  • Ensure that associated CAPAs are initiated and resolved, as assigned
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
  • Maintain metrics related to accession activities in production schedule
  • Support and participate in inspections and audits
  • Works on multiple assignments in collaborative and dynamic environment

Basic Qualifications:

  • Master’s Degree and OR
  • Bachelor’s Degree and 2+ years’ experience OR
  • AA Degree and 4+ years’ experience OR
  • High School Degree and 5+ years’ experience

Preferred Qualifications:

  • 3+ years’ experience in a in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
  • Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
  • Ability to effectively negotiate and build collaboration amongst individuals
  • Strong teamwork and collaborative skills
  • Experience with manufacturing investigations, deviations, and CAPA
  • Experience with change control practices and strategies
  • General knowledge of aseptic manufacturing processes
  • Proficient in MS Word, Excel, PowerPoint
  • Strong interpersonal, verbal, and written communication skills

*  This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.