Specialist 2, QA - Cell & Gene Therapy
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.
Due to business growth in the Cell & Gene Therapy (CGT) manufacturing, we are recruiting a Quality Specialist. The role will support the quality operations department in Cell Therapy and is responsible for planning & supporting Cell Therapy operations. The aim of this position is to develop fill-finish expertise to support the flawless execution of the Cell & Gene Therapy production process.
- Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, GMP biotech manufacturing facility.
- Planning for future activities and coordinate with other departments to complete the workflow.
- Develop skills to be Qualified Trainer in area of expertise.
- Develop in depth awareness of entire process; identifying operational factors which influence the process.
- Participates in Regulatory and Customer Audits.
- Participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.
- Ensure real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.
- Develops good working relationships with internal & external customers.
- A competent Reviewer and Approver of SOPs, protocols, reports or records.
- Lead a small team and provides supervision to QA Coordinators, interns or Specialists.
- Any other tasks as and when assigned by supervisor.
- Bachelor Degree with substantial experience in Quality Assurance in the Biopharmaceutical industry.
- Relevant QA Operations background with experience in leading small team for projects.
- Experience in deviation investigation, change control and CAPA activities.
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
- Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
- Meticulous and Systematic.
- Team player, with strong focus on safety, quality and timelines.
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 achieve 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.