Quality Assurance Specialist III

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