Full Time Quality Control Senior Scientist, Microbiology-EM Jobs, in WuXi Biologics - Maukerja

Location : Tuas Biomedical Park (company transport provided islandwide)

Job Responsibilities

• Act as the site/laboratory Subject Matter Expert (SME) and Master Trainer for environmental monitoring (EM) and clean utilities (CU), independently providing and managing training across internal and cross-functional departments.
• Perform, monitor, and oversee routine and specialized testing (including RM, EM, micro, water, gas, bioburden, endotoxin, TOC, pH, conductivity, nitrate, growth promotion, plate reading/transferring, and sterility assurance) in compliance with cGMP guidelines and internal SOPs.
• Monitor RM, EM, CU, water, and gas sampling as per strategy, and ensure EM monitoring samples are incubated properly and remain within control.
• Lead and support laboratory and environmental investigations for OOS, OOT, OOL, and atypical results/excursions; draft quality events/deviations and drive Corrective and Preventive Actions (CAPA).
• Draft, review, and execute SOPs, AMPs, RM specifications, validation protocols, qualification documents, final reports, and EM trending reports independently.
• Ensure strict compliance with GMP, GDP, training, preparation, and general lab maintenance; maintain QC notebooks/e-logbooks and worksheets for timely QA release and archival.
• Manage reagent/consumable inventories, invoicing, incoming material retention, and regulatory samples.
• Perform any other tasks assigned by the manager or supervisor as needed.

Requirement

• Diploma or Bachelor’s degree in Microbiology, Chemistry, Biochemistry, or a related scientific discipline.
• 5 - 8 years of relevant experience in a pharmaceutical, biopharmaceutical, or GMP‑regulated laboratory or manufacturing environment.
• Demonstrates ownership, accountability, and effective escalation of issues to supervisors when required.
• Adapt between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
• Willingness to support shift work or weekend work as operationally required.