Specialist 1, QA

Today, Lonza is a global leader in life sciences operating across five 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 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 QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility. Join our best-in‐class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting‐edge biotechnology and innovation. Learn new skills and capabilities. Grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video. What you'll get An agile career and dynamic working culture in a global life sciences leader. An inclusive and ethical workplace that values diversity and integrity. Competitive compensation programs that recognize high performance. Professional growth opportunities through cross‐functional projects and global exposure. Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums. Company transport provided from designated MRT locations to and from the Tuas site. Responsibilities Identify cGxP/cGDP non‐compliance, provide guidance, and support basic compliance queries across departments. Review batch records and logbooks, raise deviations, compile lot genealogy, and prepare lot disposition packages to ensure timely product release. Oversee product status, shipping documentation, material release, joint inspections, and quality tag‐out processes. Participate in deviation investigations using RCA tools and ensure timely CAPA implementation and closure. Provide QA oversight for document changes, changeovers, and Quality Change Requests. Conduct shopfloor walkdowns, escalates process events per SOPs, and support regulatory and customer audits. Lead or support QA projects and build strong working relationships with internal and external stakeholders. Demonstrate effective problem‐solving skills, data analysis, and strong interpersonal collaboration. Any other tasks as and when assigned by supervisor. Qualifications Degree in science or related field. Relevant work experience in Pharmaceutical Manufacturing industry or Validation / Quality unit in the Biopharmaceutical industry. Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7). Knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility. Team player who can operate independently, 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 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. #J-18808-Ljbffr