Quality Assurance Associate II
vor 1 Woche
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Direct message the job poster from Swisslinx
IT Recruiter @ Swisslinx | Connecting Talent to OpportunitiesIndustry: Biotechnology / Pharmaceuticals
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.
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
Seniority levelAssociate
Employment typeContract
Job functionPharmaceutical Manufacturing
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