Quality Control Senior Scientist, Microbiology/EM
WuXi Biologics · Singapore, Singapore
Tailor my CV for this job — freeLocation: Tuas Biomedical Park (company transport provided islandwide)Job ResponsibilitiesAct 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.
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