For our client, a leading biotechnology company, we are seeking a Quality Assurance/Quality Management System Associate.
...
job details
summary
- luterbach, solothurn
- temporary
- job categoryscience & research
job details
General Information:
show more- Start date: 16.02.2026
- Latest possible start date: 02.03.2026
- End date: 31.12.2026 with the possibility of extension
- Workplace: Luterbach, Solothurn
- Workload: 80%
- Working hours: Standard
- Home Office: Possible, 1 day
About the role:
As a Quality Assurance Associate, you will contribute to maintaining and strengthening the Quality Management System at the Solothurn site. In this role, you’ll support core quality activities, help coordinate routine governance processes, and assist in maintaining inspection readiness. You will collaborate with various site or global functions to ensure smooth execution of essential quality tasks. This position allows you to play an important part in sustaining a strong culture of compliance without carrying full ownership of operational responsibilities.
Tasks & responsibilities:
1. QMS Administration & Operational Support
- Support QMS processes including deviations, CAPAs, change controls, training assignments, and quality risk management in accordance with procedures.
- Collaborate with cross-functional stakeholders (QA, QC, Manufacturing, Engineering, etc.) to ensure compliance and timely completion of required actions.
- Support on KPIs reporting and monitoring
- Support on inspection readiness
2. Site Meeting Governance
- Schedule and manage logistics for site governance meetings (e.g., Investigation Review Board), including agenda preparation, pre-read collection, and documentation of decisions.
- Support governance forums related to deviations, change controls, CAPAs, and other QMS review boards to ensure consistent application of standards.
- Contribute to improving and optimizing governance meetings in line with site objectives
3. Documentation & Data Management
- Ensure accurate and compliant documentation of QMS activities in systems such as TrackWise, Veeva, and myCIMS.
- Maintain logs, trackers, meeting minutes, dashboards, and metrics related to QMS processes and governance activities.
- Identify opportunities to streamline QMS processes, improve documentation quality, and enhance visibility of compliance commitments.
Requirements:
- 3–5 years of professional experience in a similar role within the Pharma or Biotechnology industry.
- Strong technical understanding of Biotechnology API production.
- Solid expertise in GMP regulations, with specific experience or familiarity regarding US regulatory standards.
- Professional fluency in English, German is a plus.
- A self-driven professional who takes full accountability for assignments, works with high autonomy, and is comfortable giving clear instructions to move projects forward.
- Self-driven and take ownership and responsibility for own assignments.
- Value teamwork at all levels, performs work with an open-mind and ability to value input from colleagues and peers.
- Able to drive discussion to solve problems with cross functional teams.
- Able to prioritize tasks, be flexible and able to keep many activities running at a time.
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
For our client, a leading biotechnology company, we are seeking a Quality Assurance/Quality Management System Associate.
...
General Information:
show more- Start date: 16.02.2026
- Latest possible start date: 02.03.2026
- End date: 31.12.2026 with the possibility of extension
- Workplace: Luterbach, Solothurn
- Workload: 80%
- Working hours: Standard
- Home Office: Possible, 1 day
About the role:
As a Quality Assurance Associate, you will contribute to maintaining and strengthening the Quality Management System at the Solothurn site. In this role, you’ll support core quality activities, help coordinate routine governance processes, and assist in maintaining inspection readiness. You will collaborate with various site or global functions to ensure smooth execution of essential quality tasks. This position allows you to play an important part in sustaining a strong culture of compliance without carrying full ownership of operational responsibilities.
Tasks & responsibilities:
1. QMS Administration & Operational Support
- Support QMS processes including deviations, CAPAs, change controls, training assignments, and quality risk management in accordance with procedures.
- Collaborate with cross-functional stakeholders (QA, QC, Manufacturing, Engineering, etc.) to ensure compliance and timely completion of required actions.
- Support on KPIs reporting and monitoring
- Support on inspection readiness
2. Site Meeting Governance
- Schedule and manage logistics for site governance meetings (e.g., Investigation Review Board), including agenda preparation, pre-read collection, and documentation of decisions.
- Support governance forums related to deviations, change controls, CAPAs, and other QMS review boards to ensure consistent application of standards.
- Contribute to improving and optimizing governance meetings in line with site objectives
3. Documentation & Data Management
- Ensure accurate and compliant documentation of QMS activities in systems such as TrackWise, Veeva, and myCIMS.
- Maintain logs, trackers, meeting minutes, dashboards, and metrics related to QMS processes and governance activities.
- Identify opportunities to streamline QMS processes, improve documentation quality, and enhance visibility of compliance commitments.
Requirements:
- 3–5 years of professional experience in a similar role within the Pharma or Biotechnology industry.
- Strong technical understanding of Biotechnology API production.
- Solid expertise in GMP regulations, with specific experience or familiarity regarding US regulatory standards.
- Professional fluency in English, German is a plus.
- A self-driven professional who takes full accountability for assignments, works with high autonomy, and is comfortable giving clear instructions to move projects forward.
- Self-driven and take ownership and responsibility for own assignments.
- Value teamwork at all levels, performs work with an open-mind and ability to value input from colleagues and peers.
- Able to drive discussion to solve problems with cross functional teams.
- Able to prioritize tasks, be flexible and able to keep many activities running at a time.
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
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