Senior QA Specialist
vor 1 Monat
This role offers accelerated development opportunities, cross-functional collaboration, and a flexible hybrid work model. The successful candidate will join a dynamic team of contamination control experts with diverse expertise and knowledge to develop and lead the implementation of a holistic contamination control strategy on site. Ready to make an impact and progress in your career? Apply nowKey responsibilities:Provide Quality oversight for contamination control and QA microbiology oversight for QC Microbiology operations, focusing on best practices for hygiene procedures, aseptic competencies, and microbiological testing.Support QC scientists and leads throughout the different stages of the microbiological methods life cycle to ensure microbiological methods are effective and executed in a manner that is aligned with contamination-prevention principles.Lead and guide investigations of OOx results for microbiological tests. Provide microbiological expertise to support investigations, CAPAs, and Change Control related to Contamination Prevention and Control.Collaborate with cross-functional teams to provide guidance and support during OOx investigations and define and implement effective CAPAs.Ensure QC Microbiology lab processes and procedures related to contamination control topics comply with internal requirements and appropriate regulations.Participate in developing action plans to correct deficiencies to ensure the adequate microbiological quality of the lab facilities, utilities, and procedures.Analyze and interpret microbiological testing data, identify trends, and implement adequate corrective actions.Develop and deliver training programs to QC laboratory staff on contamination prevention and control, aseptic behavior, and hygiene best practices.Support regulatory inspections and customer audits as a Pharmaceutical Microbiology subject matter expert.Key requirementsBachelor's or Master's degree in a relevant scientific discipline (preferably in microbiology).Substantial GMP experience in the biologics industry, with direct QC Microbiology or relevant QA experience.Strong knowledge of contamination control principles, practices, and regulations (e.g., FDA, EMA).Knowledge of microbiological testing methods, media challenges, and microbiological control strategy is required.Fluency in English, ability to communicate in or willingness to learn German.Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.SummaryLocation: CH - VispType: Full time
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