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Senior QA Specialist, Contamination Prevention & Control EM 80-100% (f/m/d)

Lonza · Visp

Lonza is seeking a Senior QA Specialist to lead environmental monitoring and contamination prevention efforts at its Visp site, ensuring GMP compliance through data-driven oversight and complex investigations.

The Contamination Prevention & Control team at Lonza’s Visp facility produces essential GMP-compliant outputs. In this role, you will enhance quality oversight for environmental and utility monitoring by applying hands-on GMP knowledge alongside a structured, data-focused method for managing contamination risks. You will be responsible for delivering compliance-ready monitoring results and handling intricate investigations, while serving as a subject matter expert during audits and inspections.

Responsibilities

  • Prepare GMP-compliant monitoring reports that combine microbiological insights, site-specific knowledge from investigations, and facility walkdowns to support CCS maintenance and decision-making.
  • Assist in reviewing monitoring results for batch release and certification, coordinating with stakeholders to meet release timelines.
  • Analyze data from various GMP quality systems and combine it with cleanroom and production walkdown findings to identify trends and evaluate contamination control status.
  • Present and defend monitoring performance, deviations, and corrective actions as a subject matter expert during audits and inspections.
  • Maintain compliance with SOPs, GMP regulations, and internal quality standards.
  • Lead and support complex cross-functional investigations using EM data, trends, and contamination control expertise to reach well-founded conclusions.
  • Contribute to cross-departmental CCS status dashboards and other reporting and visualization tools.
  • Identify and implement continuous improvement opportunities in reporting workflows, including lean and 6S initiatives, to reduce manual effort, eliminate waste, and increase process standardization.

Requirements

  • University degree in Biology, Biotechnology, Microbiology, Chemistry, Engineering, or a related field.
  • Strong scientific and technical background with microbiology and contamination control knowledge, including familiarity with environmental and utility monitoring programs.
  • Solid understanding of GMP and regulatory requirements, with experience writing audit-ready GMP documentation such as SOPs, work instructions, and trend reports.
  • Experience presenting and defending GMP documentation and reports to auditors and inspectors in a regulated environment.
  • Strong cross-functional collaboration and communication skills in English, with German preferred.
  • Structured, proactive, and solution-oriented working style.

Nice to have

  • Experience with data science tools such as R and/or Python, or experience with Power BI or Power Automate is an advantage.
  • Experience with MODA, TrackWise, LIMS, or comparable GMP systems is preferred.

What the company offers

  • An agile career and a dynamic work culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • Relocation assistance is available for eligible candidates and their families, if needed.
  • In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.

About the company

At Lonza, the company believes that its people are its greatest strength. The organization’s core values of Collaboration, Accountability, Excellence, Passion, and Integrity define how they work together. Lonza values diversity and is committed to creating an inclusive environment for all employees, where every idea has the potential to improve millions of lives.

  • The company believes that its people are its greatest strength.
  • Core values include Collaboration, Accountability, Excellence, Passion, and Integrity.
  • Lonza values diversity and is committed to creating an inclusive environment for all employees.
  • The company fosters a culture where every idea has the potential to improve millions of lives.

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