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Quality Assurance Associate

Quality | Mountain View, CA | Full Time

Job Description

Kite Pharma Inc, founded in 2009, is dedicated to the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to fight tumor cells.  We are a dynamic and accomplished team with an exciting growth trajectory for the coming year.

The Quality Assurance (QA) Associate will provide QA oversight of clinical manufacturing of final drug product and identify and assess quality risk in activities and processes according to regulatory guidelines and standard operating procedures.  The successful candidate will be proficient in quality systems; particularly lot dispositioning, change control and exception management/CAPA. This position will report to the Director of QA and will initially be based in Mountain View, CA (likely for 6-12 months at which point the position will be relocated to Santa Monica).  A relocation bonus will be provided at that point to assist with moving espenses. 

Responsibilities (include but are not limited to):

  • Work with the Contract Manufacturing Organization (CMO) as Kite Pharma’s Quality Assurance representative
  • Coordinate and facilitate lot disposition activities and lot disposition standard lead times at CMO, including:
    • Prepare, review, and approve lot disposition
    • Ensure timely assessment and closure of Discrepancies and Change Controls requests
    • Ensure timely assessment and closure of batch hold events
    • Communicate lot disposition pending issues to Management
    • Ensure Approval/Timely Delivery of Product
  • Ensure that products are manufactured in compliance with regulatory and GMP guidelines, specifically:
    • Review/Approve Manufacturing Documents and Validation Documents for Regulatory Compliance
    • Review Manufacturing Batch Records
    • Compile and verify all batch related documents
  • Perform quality investigations of manufacturing deviations, GMP issues, system issues, non-conforming materials, and CAPAs, specifically:
    • Provide Quality Assurance support to resolving raw material, in-process material, bulk and final product, environmental, and manufacturing issues
    • Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities
    • Provide periodic updates to Management of deviations, GMP issues, system issues, non-conforming materials, and CAPAs
  • Review technical/ investigation reports as appropriate
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
  • Gather metric information for use in continuous improvement of areas of responsibility
  • Perform other duties as assigned
  • Travel may be in excess of 50%

Requirements:

  • At least 5 years of experience in quality assurance or related field within a biotechnology, biologics, or pharmaceutical manufacturing facility with a working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
  • Bachelor’s degree in technical discipline (Chemistry/Microbiology/Engineering or similar) 
  • Experience in the medical and/or pharmaceutical industry strongly preferred
  • ASQ, Black Belt/Green Belt certifications a plus
  • Experience with Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
  • Strong knowledge of GMP, SOPs and quality systems
  • Identifying, writing evaluating and closing CAPAs and experience with internal and external audit principals
  • General knowledge of aseptic manufacturing processes
  • Change control practices/strategies
  • Equipment and utility IQ/OQ/PQ/PV
  • Proficient in MS Word, Excel, Power Point and other applications
  • Strong written and verbal communication skills, including the ability to communicate and work independently with scientific/technical personnel

Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10.  We are able to offer the opportunity to be part of the first 100 employees in this successful, fast growing company.  A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.   Did we forget to mention the stock options?   To learn more about us, please visit our website at www.kitepharma.com

If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements.  All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs.  If you are not contacted for an interview, your resume will remain on file and active for available positions for one year.

No phone calls please and no agencies or recruiters