QA Specialist I

Job Description

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

As QA Associate you will:

• Perform a variety of QA activities to ensure compliance with applicable regulatory requirements and Kite procedures.
• Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good
• Laboratory Practices (GLPs).
• Review manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.
• Compiles product binders as preparation for QA disposition and QP release.
• May contribute to the Quality on the floor processes, including GEMBA walks and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good
• Laboratory Practices (GLPs), and Kite procedures.
• May provide support to deviation lead/coordinators for deviations investigations and corrective and preventive action (CAPA) relating to manufactured products, and contributes to the QA review and approval process of deviations and CAPA.
• Identify and report deviations from approved processes and procedures to senior colleagues.
• Work on assignments that are routine in nature, where ability to recognize deviation from accepted practice is required.
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory
• qualification level as needed.