Quality Assurance - Floor Specialist

at  Lonza

KEY REQUIREMENTS:

• Absolved technical apprenticeship is required, a degree in chemistry/biology/science or a related field is advantageous.
• Professional experience and GMP knowledge within a GMP manufacturing facility is required, experience in a Biologics facility is an advantage.
• Additional experience in a GMP Quality department is an advantage.
• Ability to use Microsoft Office suite and eQMS (Trackwise, DMS, and LIMs) experience.
• English professional required; German fluency is advantageous.
  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

THE ROLE:

This is an exciting new role created at BioAtrium to increase real-time oversight and support for colleagues within operations. BioAtrium is a growing organization with new projects being introduced. BioAtrium is a Biologics Drug Substance state-of-the-art facility.

KEY RESPONSIBILITIES:

• Support operations colleagues in ensuring GMP-compliant activities on the manufacturing floor.
• Support in the review and approval of process-related Change Requests, Deviation, OOS Investigations, CAPAs, and other related documents.
• Support in ensuring contamination control and being involved in contamination investigations.
• Ensure on-the-floor execution of validation and qualification protocols.
• Perform visual inspections on equipment.
• Escalation of any identified material defect or malfunction issues witnessed within the facility.
• Performs and participates in GEMBA.