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.
The Quality Assurance Officer II interacts directly with internal customers on change, CAPA and Deviation management, documentation and projects. The role is to serve as the Lonza Subject Matter Expert and decision maker for change management throughout the facility. Capable of identifying and resolving quality issues with appropriate supporting documentation. You will review and approve deviations, CAPAs and CRFs within their assigned area of focus. QA Officers must be able to weigh the risk of the event and look for an efficient yet compliant solution. The QA Officer II provides superior customer service to internal customers. Mentor and train lower level and new specialists on basic quality tasks.
- Partner with internal customer as part of moderately complex change control, CAPA, Deviation review serving as the Quality Subject Matter Expert.
- Supporting the site as final QA on all change control from the areas of MSAT, Engineering, QC, Validation and Manufacturing.
- Attend meetings prepared to speak to the project/change and identify Quality requirements.
- Consult with quality management on decisions to ensure alignment and agreement.
- Completion of QA deliverables associated with change controls (tracking, lot assessments)
- 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 deviations, CAPAs and CRFs within area of focus
- Review and approve non DMS documents
- Lead projects define project plan, scope, and deliverables as assigned. Manage and track Key Performance Indicator Quality metrics and attend other meetings- represent department at site meetings (when required)
- Perform other duties as assigned.
- Significant experience in GMP environment
- Working 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 in Batch Record reviewing
- 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
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.