Quality Assurance Associate I (80%)

Elan Computing (Schweiz) AG; Bezirk Solothurn; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Experis is seeking a Quality Assurance Associate at the Solothurn site to help maintain the Quality Management System. You will support core quality activities, coordinate governance processes, and assist in maintaining inspection readiness while collaborating with site and global functions.

You will contribute to deviations, change controls, CAPAs, and other QMS reviews, help document QMS activities in TrackWise, Veeva, and myCIMS, and uphold a culture of compliance across engineering,

Qualifikationen

• Experience in Quality Assurance or QA/QMS is desirable.
• Strong collaboration with QA, QC, Manufacturing and cross-functional teams.
• Excellent written and spoken English communication.

Aufgaben

• Audit and inspection support with timely closure and proper documentation per QMS requirements.
• Coordinate SME meetings to review action status and align on deliverables.
• Schedule and manage site governance meetings and document decisions.
• Plan, execute and track Self‑Inspection activities and observations follow‑up.
• Support QMS processes including deviations, CAPAs, change controls, training assignments and risk management; maintain documentation in QMS systems.

Kenntnisse

Good communication skills

English proficiency

Self-driven

Team collaboration

Ability to prioritize tasks

Tools

TrackWise

Veeva

myCIMS

Jobbeschreibung

Experis® is a global leader in IT professional resourcing, permanent recruitment, project solutions, and managed services. With over 25 years of experience in Switzerland and offices in Zürich, Basel, and Geneva, we connect top IT talent with leading companies. Our mission is to help professionals unlock their potential and thrive in dynamic, future-ready careers.

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.

The holder of this position will be responsible for the following activities:

Audit and Inspection Support

• Coordinate and monitor audit and inspection commitments to ensure timely closure and proper documentation in line with Biogen QMS requirements.
• Organize and facilitate meetings with SMEs to review action status, gather updates, and maintain alignment on deliverables.

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 Biogen standards.
• Contribute to improving and optimizing governance meetings in line with site objectives

Self‑Inspection Program Execution

• Assist in planning, implementing, and tracking the Self‑Inspection Program, including scheduling activities with SMEs and ensuring timely documentation and follow‑up of observations.
• Maintain tools and trackers supporting inspection readiness and compliance monitoring.

QMS Administration & Operational Support

• Support QMS processes including deviations, CAPAs, change controls, training assignments, and quality risk management in accordance with Biogen 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

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.

This position requires co-operation with people at every level of the organization and from multiple functions, including engineering, automation, validation, Manufacturing personnel, SME’s on equipment and knowledge of biotechnology API production.

Good communication skills in English, verbally and written.

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.

Be confident in making technical decisions. In addition, must be able to prioritize tasks, be flexible and able to keep many activities running at a time.

Due to Swiss work permit restrictions, we can only consider applications from EU citizens or holders of valid working permit in Switzerland.