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Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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Job Description
We are seeking a highly motivated team player with a mindset of growth, contribution, and continuous improvement to join us as a Quality Assurance Specialist III at Kite Pharma’s RDMC manufacturing site.
The Quality Assurance Specialist III ensures compliance through objective evaluation of process performance and product quality, and provides Quality Assurance support for new clinical programs, including early-phase Investigational New Drug (IND) studies and New Product Introductions (NPIs). The role ensures adherence to procedures and assesses regulatory and quality risks in accordance with regulatory agency guidance and Kite’s quality objectives. It is accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested on behalf of Kite Pharma.
Responsibilities (include but are not limited to):
Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements including but not limited to.
Support scheduling and Quality Management Review activities with oversight of key quality, product and GMP metrics.
Maintain a daily on-site QA presence to support clinical programs, including new INDs and NPIs, and the clinical manufacturing process.
Provide QA On-The-Floor support for production.
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 products.
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 to resolve material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Develop Standard Operating Procedures (SOPs) that meet quality objectives, and contribute to the training program for QA activities.
Provide day-to-day direction, coaching, and mentoring to QA staff, including assigning work, setting priorities, and supporting their professional development.
Lead and facilitate cross-functional teams and meetings to drive issue resolution and continuous improvement, and foster a collaborative, accountable, and inclusive team culture.
Collaborate and partner with cross-functional teams (Manufacturing, Supply Chain, Site QC, Process Development, Regulatory Affairs, Site QA and QS) within Kite and externally to ensure compliance, resolve issues, and build strong working relationships.
Support quality assessments of internal operations to…