Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Location/Division Specific Information
Fisher Clinical Services GmbH is a subsidiary of Thermo Fisher Scientific Inc. and is a market leader in Clinical Supply Chain Management Services and Clinical Supplies for patients worldwide.
You can find out more about our location in Weil am Rhein and Rheinfelden here:
Discover impactful Work
As a Quality Assurance Specialist (m/f/d) at Thermo Fisher Scientific, you play a critical role in ensuring compliance, quality and operational excellence within a regulated GMP/GDP environment. You support quality systems, documentation control and secondary packaging quality oversight, contributing directly to patient safety, regulatory compliance and a strong quality culture across the site.
A Day in the Life
1. Perform maintenance, quality review and approval of TrackWise Quality Records, including Investigations, CAPAs and Change Controls
2. Ensure deviations and quality events are fully documented in compliance with GMP/GDP requirements
3. Support root cause analyses and conduct effectiveness checks for CAPAs
4. Manage scheduling, coordination and communication for documentation reviews and approvals
5. Provide QA-related input to support project timelines and production planning
6. Maintain accurate, complete and audit-ready QA documentation
7. Oversee execution of QC activities in Secondary Packaging, including Start-Up checks, In-Process Controls and Final Release
8. Coordinate with QC Team Leads when operational QC tasks are delegated
9. Ensure GMP/GDP compliance across all secondary packaging quality processes
10. Support and participate in self-inspections, client audits and regulatory authority inspections
11. Conduct and support QA Gemba walks
12. Review, update and maintain SOPs
13. Analyse, report and track quality metrics to support continuous improvement initiatives
14. Proactively identify and escalate quality risks and propose mitigation actions to the Line Manager
Keys to Success
Education:
15. Completed vocational training as PTA, MTA, CTA or a comparable qualification
16. Alternatively, a scientific background with relevant pharmaceutical experience
Experience:
17. Experience in the pharmaceutical industry, preferably in GMP QA or QC
18. Experience within packaging and distribution environments is highly desirable
19. Solid GxP knowledge gained through training or practical experience
20. Experience in root cause analysis and investigation report writing is an advantage
Knowledge, Skills, Abilities
21. Strong understanding of EU GMP requirements
22. Proven ability to work in a structured, detail-oriented and compliant manner
23. Proficiency in Microsoft Word, Excel, TrackWise and electronic document management systems (eDMS)
24. Strong written and verbal communication skills and confidence working with cross-functional stakeholders
25. Excellent organisational and administrative skills
26. Fluency in German and English (B2 level or higher, written and spoken)
27. Strong team player with a proactive and quality-focused mindset
What we offer
28. Employment with an innovative, future-oriented organization
29. Outstanding career and development prospects
30. Company pension scheme and other fringe benefits
31. Exciting company culture which stands for integrity, intensity, involvement and innovation