Quality Assurance Associate III

?? Job Opportunity: Quality Assurance Associate (Contract Role)

? Location: Solothurn,…

?? Job Opportunity: Quality Assurance Associate (Contract Role)

? Location: Solothurn, Switzerland

? Contract Duration: Until end of September 2025 (possibility of extension)

? Project Focus: Cold Storage Equipment Purchase & Validation (-70°C Freezers)

? About the Role

We are seeking a Quality Assurance Associate to support a key cold storage procurement and validation project in Solothurn. This role focuses on providing QA oversight for the purchasing, qualification, and validation of -70°C freezers and related equipment, essential for supporting large-scale biotech operations.

The position is contract-based, with an initial term through September 2025 and a high likelihood of extension based on project needs.

? Key Responsibilities

• QA review and approval of:
  • Engineering and validation documentation (URS, FS, RTM, risk assessments, specs, drawings, etc.)
  • Test protocols, deviations, change controls, and related documentation
• Oversight of equipment qualification, especially -70°C freezers and cold storage systems
• Participate in purchasing decisions, equipment specifications, and vendor interactions from a QA perspective
• Ensure all validation activities comply with GMP standards and regulatory expectations
• Collaborate cross-functionally with Engineering, Automation, Validation, and Manufacturing teams

? What We're Looking For

• Strong QA experience with equipment and utility validation, especially in cold storage or ultra-low temperature (ULT) environments
• Familiarity with GMP, regulatory guidelines, and technical documentation in biotech or pharmaceutical settings
• Experience in supporting capital projects involving equipment selection and qualification
• Detail-oriented and confident in making technical QA decisions
• Strong verbal and written communication skills in English
• Ability to prioritize, work independently, and contribute in cross-functional teams

? Preferred Background

• Background in engineering, life sciences, or similar technical discipline
• Previous involvement in -70°C freezer validation or similar cold chain infrastructure projects
• Experience with computerized systems validation is a plus

? Apply Now

This is a great opportunity to contribute to a high-impact project in a fast-paced biotech environment. If you're a proactive QA professional with cold storage experience, we'd love to hear from you.