Senior QA Specialist, Contamination Control and Cleaning 80-100% (f/m/d)

Lonza Biologics Porriño SLU; Visp; Vor Ort; CHF 95’000 - 130’000; Vollzeit

Zusammenfassung

A global leader in life sciences is seeking a Senior QA Specialist for their site in Visp, Switzerland. This role involves ensuring compliance within the Contamination Control processes, collaborating with various teams, and providing quality oversight. Candidates should have a strong background in GMP contamination control and a relevant degree in sciences.

Leistungen

Agile career and dynamic working culture

Inclusive and ethical workplace

Recognition through compensation programs for high performance

Variety of role- and location-dependent benefits

Qualifikationen

• Significant GMP contamination control experience in a QA role at a large-scale facility.
• Knowledge of manufacturing processes and cleaning procedures essential.
• Fluent English communication skills; willingness to learn German is a plus.

Aufgaben

• Review and approve routine cleaning documents and lead investigations of cleaning deviations.
• Collaborate with QA Operations and other relevant teams to ensure compliance.
• Provide quality oversight for all Contamination Control Strategy topics.

Kenntnisse

GMP contamination control

Microbiology

Analytical methods

Clean procedures

Communication (English)

Ausbildung

Bachelor’s or Master’s degree in Microbiology, Chemistry, Biotechnology

Tools

TrackWise

SAP

Syncade

Microsoft Office

Jobbeschreibung

Senior QA Specialist, Contamination Control and Cleaning (80-100%) (f/m/d)

Today, Lonza is a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. We empower our employees to own their careers and genuinely improve the world. We seek individuals who want to be part of this impactful work.

The Visp, Switzerland site is expanding. For our Biologics Quality organization, we are seeking a Senior QA Specialist (f/m/d) for Large Scale Mammalian in Ibex Solutions, our innovative biological manufacturing and development platform. The successful candidate will join QA Operations and collaborate closely with key stakeholders including Contamination Prevention and Control, MSAT, Operations, and Hygiene teams.

What you’ll get:

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Recognition through compensation programs for high performance
• A variety of role- and location-dependent benefits

What you’ll do:

• Review and approve routine cleaning documents, including cleaning plans, reports, MAC plans, and QC plans
• Investigate and document all cleaning deviations; lead investigations of customer product complaints and ensure proper documentation
• Collaborate with QA Operations and teams such as Contamination Prevention, MSAT, Operations, and Hygiene
• Approve local procedures and ensure compliance with the site Contamination Control Strategy
• Provide quality oversight for all CCS topics within the facility (local CRs, DRs, DMS documents)
• Review and approve records such as SOPs, Batch Records, Material Specs, Deviations, Change Requests, and Testing Protocols & Reports

What we’re looking for :

• Bachelor’s or Master’s degree in Microbiology, Chemistry, Biotechnology, or related field
• Significant GMP contamination control experience in a QA role at a large-scale stainless steel facility
• Knowledge of manufacturing processes, cleaning procedures, and analytical methods
• Experience with GMP management systems like TrackWise, SAP, Syncade, and Microsoft Office
• Experience interacting with health authorities such as Swissmedic and FDA is preferred
• Fluent English communication skills; willingness to learn German is a plus

At Lonza, our products positively impact millions globally. We value ethical achievement, respect, and environmental protection. We challenge our staff with complex problems and innovative solutions, offering the satisfaction of making a meaningful difference in lives worldwide.