Senior QA Specialist, Contamination Prevention & Control EM

Lonza

Visp, Switzerland

As a QA Specialist, you will strengthen data-driven quality oversight within environmental and utility monitoring, combining hands-on GMP expertise with a structured, data-informed approach to contamination oversight. You will take ownership of compliance-ready EM outputs and complex investigations, acting as SME in audits and inspections.

You will contribute to how monitoring data is collected, analysed, visualised and used to support risk-based decisions and proactive contamination prevention.

What you will do:

Author GMP-compliant EM reports for EM and CU monitoring, integrating microbiological expertise, and site knowledge from investigations and facility walkdowns in support of CCS maintenance and decision-making.
Support the review of EM outputs for batch release and certification, coordinating with relevant stakeholders to ensure timely delivery in line with batch release requirements
Combine knowledge from cleanroom and production walkdowns with data collected from various GMP Quality systems to identify trends and assess contamination control status.
Present and defend monitoring performance, deviations, and related actions as SME in audits and inspections.
Ensure compliance with SOPs, GMP, and internal quality requirements.
Lead and support complex investigations across facilities and departments, using EM data and trends and contamination control knowledge to reach well-founded conclusions
Contribute to cross-departmental CCS status dashboards and other reporting and visualization tools.
Identify and implement continuous improvement opportunities within reporting workflows, including lean and 6S initiatives, to reduce manual effort, eliminate waste and increase process standardisation

What we are looking for:

University degree (PhD/Master/Bachelor) in Biology/Biotechnology/Microbiology/Chemistry/Engineering or related field.
Strong scientific and technical background ideally with microbiology and contamination control knowledge, including familiarity with environmental and utility monitoring programs.
Solid knowledge of GMP and regulatory requirements, including experience writing audit-ready GMP documentation (SOPs, work instructions, trend reports).
Experience presenting and defending GMP documentation and reports to auditors and inspectors in a regulated environment
Experience with data science tools such as R and/or Python and/or experience with Power BI or Power Automate is an advantage.
Experience with MODA, TrackWise, LIMS, or comparable GMP systems is preferred.
Ability to work autonomously, take ownership of deliverables, and drive tasks forward independently while managing competing priorities across routine and strategic workstreams.
Strong cross-functional collaboration and communication skills in English and preferrably in German.
Structured, proactive, and solution-oriented working style.