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Quality Assurance Specialist III

United States - California - Santa MonicaQualityRegular

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. Does this sound exciting to you?

Apply today!

We are seeking a Quality Assurance Specialist III to join our growing Quality team.

Responsibilities include, but are not limited:

  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Disposition raw materials globally to Kite manufacturing network across all sites and countries
  • Train QA staff across Quality on material disposition process
  • Author of QA curriculum for material disposition
  • QA approver on critical quality records (Deviation, CAPA, LIR, Change Controls) including QA consultations to quality records owners
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
  • Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
  • Proficient in systems such as GVault, EBS, AGILE and GxPLearn systems 
  • May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • Works with Research and Development during new product start-ups, and identifies routine checkpoints for new products and processes.
  • May assist with compliance audits as required.
  • Interfaces with contract manufacturers to address documentation and compliance issues.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
  • Normally receives no instruction on routine work, general instructions on new assignments.

Basic Qualifications:

  • High School Diploma with 10+ years of relevant experience in a GMP Environment
  • Associates Degree with 8+ years of relevant experience in a GMP Environment
  • BA or BS with 6+ years of relevant experience in a GMP Environment
  • MS or MA with 4+ years of relevant experience in a GMP Environment

Preferred Qualifications:

  • Prior experience in pharmaceutical industry is preferred
  • Proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
  • Proficiency in application of QA principles, concepts, industry practices, and standards
  • Demonstrated thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance
  • Strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
  • Audit and investigation skills, and report writing skills
  • Strong verbal, technical writing and interpersonal skills
  • Proficiency in Microsoft Office applications