QA Specialist II

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

• Review batch-related documentation and ensure resolution of issues to release product.
• Perform comprehensive quality review of batches for disposition.
• Ensure process control measures are in place and followed in product manufacturing.
• Ensure all product-related Deviations are initiated, investigated and resolved.
• Ensure that associated CAPAs are initiated and resolved, as needed.
• Generate and update procedures, forms and other documents.
• As assigned, manage and provide QA oversight for other processes, including training, warehouse /inventory, redose, new product introductions, etc.
• Maintain production (finite ), disposition, and team schedules Represent Disposition or QA Ops at plant and multi-site scheduling meetings.
• Provide QA representation at multi-site disposition meetings
• Provide QA representation on projects and at team meetings
• Maintain metrics related to product disposition in support of the Management Review and for continuous improvement.
• Support and participate in inspections and audits.
• Additional duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

• Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, or a related scientific discipline.
• Minimum 3-4 years of experience in a regulated pharmaceutical, biotechnology, cell therapy, medical device, or GMP manufacturing environment.
• Working knowledge of cGMP regulations, FDA requirements, and applicable quality systems.
• Experience reviewing and approving GMP documentation, including batch records, deviations, CAPAs, change controls, and investigations.
• Strong attention to detail with the ability to identify compliance risks and quality concerns.
• Demonstrated ability to make quality decisions based on data, procedures, and regulatory requirements.
• Effective written and verbal communication skills with the ability to interact across Quality, Manufacturing, Supply Chain, and Technical Operations.
• Proficiency in electronic quality management systems, document management systems, and Microsoft Office applications.

• 2-3 years of QA Operations, batch disposition, product release, or manufacturing quality experience in biotechnology, cell therapy, or pharmaceutical manufacturing.
• Experience performing lot disposition and product release activities in a GMP environment.
• Knowledge of cell therapy manufacturing processes and associated quality requirements.
• Experience with electronic batch records, Veeva Vault, MES, SAP, or similar quality/manufacturing systems.
• Strong understanding of deviation management, risk assessments, change control, and data integrity principles.
• Ability to manage multiple priorities in a fast-paced manufacturing environment while maintaining compliance.
• Experience supporting internal and external audits and regulatory inspections.
• Demonstrated ability to influence…