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Expert, Quality Control

External
Lonza logoLonza · Sg - Tuas, Singapore
Full-timeOn-siteToday
AgileComplianceLeadershipMentoring
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Responsibilities

  • Serve as a Subject Matter Expert (SME) for Quality Control testing, providing advanced technical expertise, troubleshooting support, and strategic guidance within your area of specialization.
  • Lead and oversee laboratory activities including testing, assay transfers, method validation, technical reviews, equipment troubleshooting, and laboratory compliance programs.
  • Drive complex investigations including Out-of-Specification (OOS), deviations, trend analysis, root cause investigations, and CAPA implementation to ensure timely and effective resolution.
  • Support customer, site, and stability projects by coordinating cross-functional activities, managing project deliverables, and ensuring successful execution of project objectives and timelines.
  • Author and approve technical documents including Change Controls, SOPs, test methods, assay trend analyses, validation documents, and technical reports.
  • Act as a technical leader by coaching and mentoring team members, supporting capability development, participating in global forums, and driving departmental KPI achievement.
  • Support regulatory inspections, customer audits, innovation initiatives, data integrity programs, and continuous improvement activities to enhance QC capabilities and operational excellence.

Requirements

  • Degree in Biochemistry, Chemistry, Biotechnology, Microbiology, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
  • Significant Quality Control experience within a GMP-regulated pharmaceutical, biotechnology, biologics, cell therapy, or life sciences environment.
  • Demonstrated technical expertise in one or more areas including Product Testing, Raw Material Testing, Microbiology/Environmental Monitoring, Stability Programs, or Cell Therapy testing.
  • Hands-on experience with advanced analytical techniques such as HPLC, ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, TOC, Flow Cytometry, spectroscopy, compendial testing, or environmental monitoring methods.
  • Strong experience in method validation, assay transfer, laboratory investigations, CAPA management, trend analysis, and quality system processes.
  • Proven ability to lead cross-functional projects, support regulatory inspections and audits, influence stakeholders, and manage multiple priorities effectively.
  • Strong communication, coaching, analytical, and problem-solving skills with a passion for continuous improvement, innovation, and operational excellence.
  • About Lonza
  • Ready to shape the future of life sciences?

Additional Information

Location: Tuas, Singapore Be part of Lonza's Quality Control team and play a key role as a technical expert supporting the quality and compliance of products that improve lives around the world. As an Expert, QC, you will serve as a Subject Matter Expert (SME) in your area of specialization, providing advanced technical leadership, driving laboratory excellence, and supporting strategic projects across the site. In this role, you will lead complex investigations, support regulatory inspections, mentor team members, and collaborate with global stakeholders to ensure the highest standards of quality, compliance, and operational performance. What you will get - An agile career and dynamic working culture. - An inclusive and ethical workplace. - Compensation programs that recognize high performance. - Opportunities to collaborate with global cross-functional teams. - Ongoing learning and professional development opportunities. - Our full list of global benefits can be found here: Lonza Benefits .


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