QA Specialist

• Implement contamination control & sterility assurance actions at site.
• Participate in global CCSA community, perform site assessment, learn best practices and lead site improvement.
• Ensure master set testing and documentation per plan for product claims:
• Plan master set testing for all site products;
• Ensure production orders for master set samples are released on time;
• Send master sets to respective testing and irradiation locations;
• Track sample status and collect test results;
• Document test results for product claims.

• Answer customer inquiries and audit questions on product cleanliness & sterility.
• Support site projects, initiatives, and external audits.
• Perform testing and release of experimental samples, finished products, and raw materials.
• Conduct routine physicochemical testing, microbiological limit testing, and endotoxin testing in accordance with approved procedures.
• Accurately record, review, and report test results, ensuring data integrity and traceability.
• Support the maintenance of the laboratory quality management system, including participation in deviation, OOS, and change control activities.
• Operate, maintain, and document the use of laboratory instruments and equipment.
• Assist with internal and external audits and inspections as required.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

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