Senior Scientist QA Operations
Thermo Fisher Scientific · Lengnau, Switzerland
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Role summary
Thermo Fisher Scientific seeks a Senior Scientist for QA Operations in Lengnau, Switzerland. The role involves ensuring compliance with quality standards, leading investigations, implementing corrective actions, and driving continuous improvement across manufacturing operations in regulated environments.
What they're looking for
- Advanced degree with no prior experience, or bachelor's degree plus 2 years QA experience in GMP/ISO environments
- Life sciences, engineering, chemistry, or related scientific/technical field
- Strong knowledge of cGMP regulations, ISO 13485, and 21 CFR Part 820
- Expertise in quality tools: risk management, root cause analysis, CAPA, change control
- Proficiency with quality management software (TrackWise, SAP QM) and Microsoft Office
- ISO 13485/FDA Lead Auditor or ASQ certification (CQE, CQA) advantageous
- Demonstrated experience leading investigations and implementing corrective actions
What you'll be doing
- Ensure compliance with quality standards and regulatory requirements across manufacturing operations
- Lead quality investigations, analyze data, and implement effective corrective actions
- Develop standard operating procedures, protocols, and quality documentation
- Conduct internal audits and support external regulatory inspections
- Drive continuous improvement initiatives through cross-functional collaboration
Privacy & handoff
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