Associate II, Quality Assurance

Kincell Bio engineers cells into therapies. Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

Requirements

• Actively participates in fostering a positive, collaborative work
• Ensuring adherence to cGMPs across the
• Addresses all quality and compliance matters in an open and timely
• Evaluating standard operating procedures, master batch records, and test methods for alignment with GMPs.
• Performs review of all product-related documents such as production batch records, testing forms, logbooks, etc.
• Supports raw material and finish product release
• Supports deviation, CAPA, and change control
• Maintains databases used for tracking various lot disposition
• Support regulatory (FDA, EMA) and client audits/inspections.

Benefits

• Competitive benefits