Senior QA Specialist

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible. The Sr. QA Specialist is responsible for implementing contamination control & sterility assurance actions at site, participating in global CCSA community, performing site assessment, and leading site improvements with best practices. This position reports to the Senior QAQC Manager and is part of the located in and will be an on-site role. What you will do: 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. Who you are: Bachelor or Master in a scientific field, preferable in Life Sciences, e.g. bio, biomedical, chemistry, chemical, pharma, … Willing to collaborate with cross-functional team toward a common goal Track record of working in a cleanroom environment Certified internal auditor for ISO 13485 Project management experience Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. 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.