Quality Control Senior Scientist, Microbiology/Environmental Monitoring

About the role

A Quality Control Senior Scientist is needed at Tuas Biomedical Park, covering microbiology and environmental monitoring (RM, EM, micro, water, gas, bioburden, endotoxin, TOC, pH, conductivity, nitrate, growth promotion, plate reading/transferring and sterility assurance). The role acts as the site and laboratory subject matter expert and master trainer for environmental monitoring and clean utilities, with company transport provided islandwide.

Key responsibilities

• Provide and manage training independently across internal and cross-functional departments on environmental monitoring and clean utilities.
• Perform, monitor and oversee routine and specialized testing in compliance with cGMP guidelines and internal SOPs.
• Monitor RM, EM, CU, water and gas sampling according to strategy, ensuring EM samples are incubated properly and stay in control.
• Lead and support laboratory and environmental investigations for OOS, OOT, OOL and atypical results, draft quality events and deviations, and drive CAPA.
• Draft, review and execute SOPs, AMPs, RM specifications, validation protocols, qualification documents, final reports and EM trending reports.
• Maintain QC notebooks/e-logbooks and worksheets for timely QA release and archival, and ensure compliance with GMP, GDP, training, preparation and lab maintenance.
• Manage reagent and consumable inventories, invoicing, incoming material retention and regulatory samples.

Required profile

• Diploma or Bachelor's degree in Microbiology, Chemistry, Biochemistry or a related scientific discipline.
• 5 to 8 years of experience in a pharmaceutical, biopharmaceutical or GMP-regulated laboratory or manufacturing environment.
• Ownership and accountability, with effective escalation of issues to supervisors when required.
• Ability to adapt between strategic and tactical thinking, manage multiple priorities and support shift or weekend work as operationally required.