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

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. Would you like to join us in this mission?

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist. In this role you will support the activities of the Quality Assurance department at Kite’s Santa Monica Clinical manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives.


Responsibilities (included but not limited to):

  • Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
  • Provide QA support on the floor for production up to 50 % of the time
  • Ensure process control measures are in place and followed in product manufacturing, provide guidance to manufacturing on following controls
  • Receipt and disposition of incoming apheresis material
  • Oversee and authorize shipment of final product
  • Verify and ensure timely issuance of production documents and labels
  • Review batch-related documentation and ensure resolution of issues to release and ship product
  • Gather and report metrics to measure performance
  • Identify and lead continuous improvement actions in QA
  • Ensure timely resolution and escalation of issues
  • Ensure all product-related Deviations are initiated, investigated and resolved
  • Ensure that associated CAPAs are initiated and resolved, as needed
  • Perform lot closure activities
  • Ensure approval and timely delivery of final product
  • 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
  • Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met
  • Participate in development of QA activities training program
  • Perform other duties as assigned

Basic Qualifications:

  • Master’s Degree and 2+ years’ experience of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
  • Bachelor’s Degree and 4+ years’ experience of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
  • AA Degree and 5+ years’ experience of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
  • High School Degree and 6+ years’ experience in of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product)

Preferred Qualifications:

  • Sound 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
  • Working knowledge and experience with manufacturing investigations, deviations, and CAPA
  • Working knowledge of aseptic manufacturing processes
  • Proficient in MS Word, Excel, Power Point and other applications
  • Strong interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
  • Willingness to think outside of the box and adapt best practices to a small, but growing environment
  • Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description

Does this sound like you? If so, apply today!

* 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.