QA Specialist

Implement contamination control & sterility assurance actions at site.

About Danaher

• 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.
• For more information, visit www.danaher.com .

Responsibilities

• 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.