QC Analyst, Environmental Monitoring

About the role

Lonza is hiring an Environmental Monitoring (EM) QC Analyst in Singapore (site-based, shift role) to carry out environmental monitoring that keeps cleanroom and manufacturing areas meeting GMP quality and safety standards for the production of medicines. The role is fully site-based and involves close, real-time collaboration with colleagues.

Key responsibilities

• Perform microbiological testing (bioburden, LAL, plating/counting, microbial identification, EM sampling, particulate monitoring)
• Carry out air, surface, viable and non-viable environmental monitoring across manufacturing and cleanroom areas
• Analyse raw material, in-process, environmental and finished product samples according to SOPs and GMP requirements
• Document, review and report results in line with cGMP and data integrity standards
• Support trending, investigations and deviation/OOS activities, including root cause analysis
• Maintain laboratory operations: equipment upkeep, housekeeping, reagents, consumables and inventory control
• Manage sample logistics, retention samples, external testing coordination and QC documentation and shipping
• Prepare and maintain GMP-compliant standards and reagents, and prepare reports on time
• Take part in peer review and continuous improvement, and perform other duties assigned by the manager

Required profile

• Degree in science or a related field
• Relevant work experience in pharmaceutical or biopharmaceutical manufacturing
• Familiarity with regulatory requirements and local codes and standards such as FDA, EMEA and ICH Q7
• Knowledge of quality management systems in GMP facilities
• Team player able to work independently, with a strong focus on safety, quality and timelines

What we offer

• Competitive compensation programs and shift allowances
• Medical insurance with the option to include family members at partially subsidised premiums
• Company transport from designated MRT stations to and from the Tuas site
• Cross-functional projects and global exposure for professional growth
• Full range of employee benefits