Quality Systems Specialist III

Kite Pharma
El Segundo, CA, United States
Sep 11, 2019
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated individual to join as a Quality Systems Specialist III located at Kite's Commercial manufacturing site in El Segundo, CA. Reporting into the Quality Systems and Compliance Manager, you will provide oversight of Kite's quality systems (Deviations, CAPA, EV, and Change Control).

Responsibilities (include but are not limited to):
  • Establish and maintain a Deviation, CAPA, EV and Change Control Management System compliant with regulatory, quality, and Kite requirements.
  • Provides guidance and advice on methods, procedures, standardization and requirements associated with these systems.
  • Collaborates with cross-functional departments to ensure timely implementation of quality records.
  • Support audits (internal, external) in order to verify that regulatory and quality requirements have been met.
  • Support Deviation system and ensure proper investigation and root cause analysis are performed.
  • Support CAPA/EV system to ensure proper corrective actions are implemented and effective.
  • Support Change Control system to ensure proper change and impact assessments are performed and tasks are implemented.
  • Develops, implements and delivers training content for Deviation, CAPA, EV and Change Control processes and procedures.
  • Responsible for procedure reviews and facilitating procedure updates for the Deviation, CAPA, EV and Change Control systems.
  • Assure that personnel are adequately trained in the principals, policies, and procedures of the Deviation, CAPA, EV and Change Control systems.
  • Support tracking and communication of site metrics to management.
  • Identify and escalate compliance gaps across quality systems.
  • Perform other duties as required.
  • The standard work week for this position is M-F with occasional weekend work required.

  • 6+ years of relevant experience in a GMP environment related field and a BS.
  • 4 + years of relevant experience and a MS.
  • Strong knowledge of GMP, SOPs and quality system processes.
  • Excellent organizational skills and ability to review and update processes or procedures.
  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Experience in pharmaceutical or bio-pharmaceutical field.
  • Education or training in cell culture and gene therapy manufacturing environment a plus.
  • Proficient in drafting and completing technical documents and presentations.
  • Expertise in document management processes.
  • Works on multiple assignments in collaboration with various department system owners.
  • Quality systems demonstrated knowledge in areas such as Deviation, CAPA, EV and Change Control system management practices/strategies.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.



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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