Senior Quality Assurance Specialist

vor 1 Woche


Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit
Job Summary

We are seeking a highly skilled Microbiologist to join our team at Thermo Fisher Scientific Inc. in a Sterility Assurance role. As a Sterility Assurance Specialist, you will be responsible for ensuring the highest standards of sterility and microbial control in our manufacturing areas.

Key Responsibilities
  • Oversee quality assurance of all sterility-related topics.
  • Develop and implement overall microbial control concepts.
  • Review and approve protocols, reports, procedures, and other relevant documents required for contamination control strategy, contamination investigation, and sterility hold time validation activities.
  • Contribute to the implementation of Lifecycle Validation concepts and act as Subject Matter Expert for the area of responsibility during health authority inspections and customer audits.
  • Perform environmental monitoring to ensure sterility in manufacturing areas.
  • Investigate and resolve sterility-related issues.
Requirements
  • Master Degree in Microbiology or equivalent experience in the field.
  • Proven experience (minimum 3 years) in microbiology in the pharmaceutical industry.
  • Strong knowledge of sterility assurance principles and regulations.
  • Exceptional attention to detail and analytical skills.
  • Excellent communication and collaboration abilities.
  • Language: Fluent English required, with some proficiency in German beneficial (written and spoken).
About Us

Thermo Fisher Scientific Inc. is a world leader in serving science, with a commitment to delivering world-class products and services. We are a highly ambitious team dedicated to excellence.



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