QA Officer mRNA Level 2

Netherlands, Geleen

Today, Lonza is a global leader in life sciences operating across three 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.

We have recently been confirmed as the global manufacturing partner for Moderna’s vaccine against the novel coronavirus, providing a tenfold manufacturing capacity increase. As other businesses face increasing economic uncertainty, we are fortunate to have opportunities for expansion. Through this new collaboration, our work will have a significant, direct and long-term impact on the management of this global pandemic.

The Quality Officer 2 interacts directly with internal customers on change management documentation and projects.  The role is to serve as the Lonza Subject Matter Expert with support from senior QA/ QA Project Managers and Management for change management throughout the facility.   Capable of identifying, defending, and resolving quality issues with appropriate supporting documentation.  QA Officer 2 must be able to weigh the risk of the event and look for the efficient yet compliant solution. The QA Officer will ensure superior customer service to internal customers.

Key responsibilities:

  • Partner with internal customer as part of minor/non-complex change control , CAPA and Deviations. 
  • Issuance, verification, review of the Batch records, related deviations, CAPAs and CRF as well as OOS and EMP investigations.
  • Review and approve Lonza SOPs, forms, and test methods within Document Management System.  Responsibility is to ensure changes are justified; procedures are followed, and contain appropriate associated reference
  • Review and  approve non DMS documents (executed work orders, Engineering Preventative Maintenance documents, Environmental Action Reports)
  • Manage and track Key Performance Indicator Quality metrics- represent department at site meetings (lot release, Deviation board, quality council when needed)
  • Perform other duties as assigned

Key requirements:

  • Knowledge of GMP’s and regulations in Quality environment
  • Experience with Trackwise, SAP, Document Management System preferred
  • Experienced in Batch record reviews
  • Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with teams

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R39400