Analyst, QC(EM)

Responsibilities

• Perform microbiological testing (bioburden, LAL, plating/counting, microbial identification, EM sampling, particulate monitoring).
• Conduct environmental monitoring (air, surface, viable, and non-viable sampling) across manufacturing and cleanroom areas.
• Analyze raw materials, in-process, environmental, and final product samples per SOPs and GMP requirements.
• Document, review, and report results in compliance with cGMP and data integrity standards.
• Support trending, investigation, and deviation/OOS activities, including root cause analysis.
• Maintain laboratory operations (equipment upkeep, housekeeping, reagents, consumables, and inventory control).
• Manage sample logistics including retention samples, external testing coordination, and QC documentation/shipping.
• Prepare and maintain GMP-compliant standards and reagents.
• Ensure timely testing and reporting to meet operational and production needs.
• Participate in peer review and continuous improvement initiatives.
• Uphold strict data integrity and GMP compliance at all times.
• Perform additional duties as assigned by the manager.

Requirements

• Degree in science or related field
• Relevant work experience in Pharmaceutical Manufacturing industry or 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
• About Lonza
• Ready to shape the future of life sciences?

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Company Intel

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