Senior QA Specialist, Microbial Contamination Control & Cleaning

Senior QA Specialist, Microbial Contamination Control & Cleaning

Lonza

Visp, Switzerland

What you will do:

• Lead the Bioconjugates contamination control strategy, ensuring end to end compliance across Bioconjugates manufacturing facilities.
• Lead CCS-related topics, such as bioburden control strategy, hygiene, environmental monitoring, etc (managing Risk and Gap Assessments, Change Requests, Deviations, Investigations, CAPAs, etc.) in Bioconjugates.
• Author and approve GMP documentation and records, including: SOPs, deviations, change controls, and risk assessments
• Partner closely with cross‑functional teams to identify risks, drive deviation management & continuous improvement, and strengthen contamination prevention control practices.
• Lead the identification, assessment, and mitigation of contamination risks and maintaining the Contamination Control Strategy (CCS) within Bioconjugates.
• Guide and influence stakeholders by providing microbiology and QA expertise, ensuring robust quality culture and operational compliance.
• Act as QA Microbial Contamination Control and cleaning SME in meetings with the relevant stakeholders, and customers, in audits and inspections.
• Review and approving the routine cleaning-relevant documents, i.e., routine cleaning plans and reports, MAC plans and cleaning QC plans.
• Responsible for the review and final release of records like Standard Operating Procedures (SOPs), Master Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
• Identify emerging QA relevant topics, communicating to the relevant stakeholders and working actively on their development into new or already established Quality and Compliance strategies and/or standards i.e., CAPAs.
• Support continuous improvement programs to establish effective Quality Contamination Control.

What we are looking for:

• Academic degree in Chemistry/Biotechnology/Life Science or related field.
• Extensive experience in the GMP-regulated pharmaceutical industry; experience in microbial contamination control and Environmental Monitoring programs with practical understanding is required.
• General knowledge of manufacturing processes, contamination control strategy, cleaning procedures and analytical methods.
• Demonstrated ability to act proactively with a detail‑oriented, problem‑solving and continuous‑improvement mindset.
• Experience in the interaction with health authorities (Swissmedic, FDA etc.) is desired.
• We are looking for someone who is independent, sociable, pro-active, customer focused and who values working as a tea m player.
• Experience with TrackWise, SAP, and Microsoft Office software is preferred.
• Fluency in English is required; German would be an asset.