Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
As a Specialist, QA (Quality External) at Lonza, you will monitor and support day-to-day Quality Assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility. In this fixed term contract role, you will provide QA oversight in quality compliance and audits, support regulatory inspections, and collaborate cross-functionally to ensure the highest level of quality and compliance with cGMP standards.

• Support and participate in Regulatory Inspections and Customer Audits, including front room/backroom roles.
• Lead complex deviation investigations and review/approve deviations, change controls, trend investigations, supplier notifications, and CAPA plans.
• Perform material release and qualification, joint inspections, and vendor investigation reviews.
• Coordinate and deliver Supplier Quality Agreements in a timely manner.
• Own documents for assigned Quality Processes and support document management activities.
• Support continuous improvement, troubleshooting, and process pathway development for strategy improvements.
• Ensure adherence to data integrity principles in line with Lonza policies, proactively identifying and improving data integrity processes.
• Perform other duties as assigned by supervisor.