Overview
Quality Assurance Associate II Jobs in Solothurn, Switzerland at Swisslinx
Title: Quality Assurance Associate II
Company: Swisslinx
Location: Solothurn, Switzerland
Location: Solothurn, Switzerland
Industry: Biotechnology / Pharmaceuticals
Job Type: Full-time
About the Role
We are seeking a highly motivated Associate III – Integrated Downstream Quality Operations to join our Quality Department at our state-of-the-art Large-Scale Manufacturing facility in Solothurn, Switzerland. This role plays a key part in ensuring GMP compliance, quality assurance, and process excellence for downstream manufacturing and equipment.
Key Responsibilities
Oversee QA activities related to downstream operations, GMP manufacturing, and equipment to maintain product safety, efficacy, and purity.
Review and approve GMP engineering and manufacturing documents, including procedures, work instructions, deviations, CAPAs, change control, and equipment qualification protocols.
Collaborate with Manufacturing, Process Engineering, and Automation SMEs to manage investigations and deviations.
Support column packing/unpacking and chromatography review activities.
Ensure adherence to internal procedures during downstream operations, equipment controls, and new product introductions.
Participate in batch record review and closeout for batch release.
Qualifications & Experience
Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, or a related field, with 5+ years of experience in pharmaceutical/biotech manufacturing.
Master’s degree in a relevant field with 3+ years of experience in pharmaceutical/biotech manufacturing.
Experience in Quality Assurance, Equipment Qualification, and Downstream Processing is preferred.
Strong problem-solving, organizational, and presentation skills.
Excellent technical writing and documentation skills.
Ability to work independently and collaborate with cross-functional teams.
English proficiency (B1 minimum).
Why Join Us?
✔ Work in a cutting-edge biopharmaceutical manufacturing facility.
✔ Be part of a collaborative and innovative team.
✔ Opportunity for professional growth in a fast-paced and high-impact environment.
Ready to make an impact? Apply now and become part of a team shaping the future of biopharmaceutical manufacturing!
