? Job Opportunity: Quality Assurance Associate
? Location: Bern, Switzerland
? Start…
Job description:
? Job Opportunity: Quality Assurance Associate
? Location: Bern, Switzerland
? Start Date: 01 July 2025
? End Date: 30 June 2026
? Full-time - 12-month contract, possible extension
Are you ready to contribute to life-saving therapies while developing your expertise in aseptic manufacturing and GMP compliance? We are looking for a dedicated and detail-oriented Quality Assurance Associate to join our team.
?
Your Key ResponsibilitiesAs part of our Quality Assurance team, you will:
- Provide support and guidance in the areas of aseptic manufacturing and microbiological laboratories (no hands-on lab/manufacturing work).
- Ensure GMP compliance in production by performing regular checks and process reviews.
- Actively contribute to projects including:
- Commissioning a new aseptic filling line
- Implementation of regulatory updates (e.g., EU GMP Annex 1)
- Review and document production processes, workflows, and quality standards.
- Support and (re)qualify production personnel through training initiatives.
- Provide on-site quality support during manufacturing, with a focus on compliance and risk assessment.
- Manage and investigate complex deviations in aseptic filling and visual inspection:
- Initial evaluation and risk classification
- Support definition of investigation strategies and technical assessments
- Collaborate on CAPA development to prevent recurrence
- Review deviation reports (German & English) for compliance and risk accuracy
- Prepare and present deviations during internal and external audits.
- Review SOPs and other quality documentation.
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Your Profile- Degree in a life sciences field (BSc, MSc or PhD) or equivalent qualification
- Minimum 2 years of experience in a GMP-regulated environment, ideally in the pharmaceutical industry
- Strong analytical thinking with the ability to present complex topics clearly and logically
- Critical thinking and keen eye for structured, high-quality documentation
- Team player with strong communication and influencing skills across all levels
- Flexible, proactive, and able to manage multiple priorities
- Fluent in German (native level) and business fluent in English, both written and spoken
- Comfortable working in a mixed office/cleanroom setting (approx. 80% office, 20% cleanroom - Grade C/D/E)
? What We Offer
- A unique opportunity to work in a global biopharmaceutical environment with a clear mission to save lives
- Dynamic and supportive team culture
- Professional development in quality assurance and aseptic manufacturing
- Exposure to cutting-edge facilities and technologies
? Apply now to become a vital part of our quality team and contribute to the safe production of life-changing therapies.