Quality Assurance Associate
Location: Solothurn, Switzerland
Start Date: ASAP - 31/12/2026
Workload: 80%
Key Responsibilities
QMS Administration & Operational Support
* Support core QMS processes including deviations, CAPAs, change controls, training assignments, and quality risk management.
* Collaborate with stakeholders across QA, QC, Manufacturing, Engineering, and other functions to support timely and compliant completion of quality actions.
* Assist with the preparation, tracking, and reporting of QMS KPIs and metrics.
* Contribute to maintaining inspection readiness and support routine audit preparation activities.
Site Governance & Meeting Coordination
* Schedule and coordinate logistics for site governance meetings (e.g., Investigation Review Board).
* Prepare agendas, collect prereads, and document outcomes and decisions.
* Support governance forums related to deviations, CAPAs, change controls, and other QMS processes.
* Help identify opportunities to improve meeting efficiency and standardization.
Documentation & Data Management
* Ensure compliant and accurate documentation within QMS systems such as TrackWise, Veeva, and myCIMS.
* Maintain trackers, logs, dashboards, meeting minutes, and other data sources related to QMS governance.
* Support continuous improvement by identifying ways to streamline QMS documentation and enhance visibility of compliance commitments.
Key Requirements
* Background in Life Sciences, Biotechnology, Engineering, or a related technical field (education level flexible depending on experience).
* Experience in QA, manufacturing, or GMP‑regulated environments is an advantage, but not mandatory.
* Understanding of biotechnology production processes is beneficial.
* Strong communication skills in English (written and verbal).
* Ability to collaborate with personnel across all organizational levels and functions (Manufacturing, Validation, Automation, Engineering, etc.).
* Self‑driven, solution‑oriented mindset with the ability to take responsibility for assigned tasks.
* Strong organizational skills with the ability to manage multiple activities simultaneously.
* High attention to detail, accuracy, and adherence to compliance standards.
* Comfortable making technical decisions and driving discussions to support issue resolution.
* Candidate must hold an EU passport or valid Swiss Work Permit
SThree_Germany is acting as an Employment Business in relation to this vacancy.