QA Raw Materials Specialist

Netherlands, Geleen

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Raw Materials Specialist you interact directly with Lonza’s internal and external customers for disposition of materials, resolution of release issues and other material related work as needed.  As an established Subject Matter Expert (SME) in the material receipt, testing and disposition process, you will be expected resolve complex issues, triage issues for escalation to area management and train junior staff members.

Providing resolution to escalated issues within their area of responsibility and will help define the strategy for remediation of escalations/issues and improvements efforts. The Specialist will also be expected to perform all associated SAP transactions as part of the release as well as other Quality functions within SAP. Little direction and coaching for day to day activities, are expected to be subject matter experts to the associated workflows and able to manage the escalation of issues.

Key responsibilities:

  • Review, manager and ensure compliance with GMP regulations for raw materials pertaining to commercial manufacturing
  • Serves as the SME for internal and external customers on technical transfers
  • Works with project teams to on-board raw materials
  • Update and revise SOPs as required to ensure compliance
  • Keeps up to date with compliance and regulation guidelines within the industry
  • Understands and makes informed decisions pertaining to testing and testing selections for materials
  • Supporting the site as final QA on all change control from the areas of MSAT, PW&L
  • Attend meetings prepared to speak to the project/change and identify Quality requirements
  • Consult with quality management on decisions to ensure alignment and agreement
  • Perform other duties as assigned

Key requirements:

  • Extensive experience in a GMP environment
  • Extensive experience in Quality Assurance or similar discipline
  • Biotechnology manufacturing background is preferred
  • Knowledge of GMP’s and regulations. Experienced professional who continues to improve and refine technical knowledge of quality systems
  • Experience with Trackwise, SAP, Document Management system
  • Self-starter, excellent written and verbal communicator at all levels, able to maintain composure, pays close attention to detail, works effectively individually and with all team members. Able to manage multiple activities within agreed timeframes with a challenging workload and changing priorities

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: R28983