QA Specialist I

We’re here for one reason – to cure cancer. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

Requirements

• Provide QA support on the floor for production in manufacturing and in the QC labs.
• Ensure process control measures are in place and followed in product manufacturing.
• Perform apheresis accession of incoming patient material.
• Perform shipment authorization of final product.
• Review batch-related documentation and ensure resolution of issues to release and ship product.
• Real-time review of exceptions, Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs) on the manufacturing floor.
• Gather and report metrics to measure performance.
• Identify and participate in continuous improvement activities.
• Ensure timely resolution and escalation of issues.
• Ensure quality records are initiated for deviating events observed on the floor.
• 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.

Benefits

• Paid time off
• 401k Matching
• Retirement Plan
• Life insurance plans
• Medical, dental, vision insurance plans