Quality Control Senior Scientist, Microbiology/EM

WuXi Biologics; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

WuXi Biologics in Singapore is seeking an experienced professional to serve as the site SME and Master Trainer for environmental monitoring and clean utilities. You will independently provide training across internal and cross-functional departments and oversee routine and specialized testing to ensure GMP compliance.

The role requires 5–8 years of relevant GMP laboratory experience, strong ownership and escalation skills, and the ability to adapt between strategic and tactical work while

Qualifications

• Diploma or Bachelor's degree in Microbiology, Chemistry, Biochemistry, or related science.
• 5-8 years experience in pharmaceutical/biopharmaceutical GMP environment.
• Ownership, accountability and ability to escalate issues to supervisors.
• Adaptable to shifting priorities and able to manage multiple tasks.
• Willingness to support shift or weekend work as required.

Responsibilities

• Act as SME and Master Trainer for environmental monitoring and clean utilities, delivering training across departments.
• Perform, monitor and oversee routine and specialized testing in compliance with cGMP and SOPs.
• Monitor sampling and ensure EM samples are incubated and within control.
• Lead investigations for OOS/OOT/OOL and CAPA, drafting quality events.
• Draft, review and execute SOPs, RM specs, validation protocols and final reports.
• Maintain GMP/GDP compliance, QA notebooks and archiving for QA release.
• Manage reagents, inventories, invoicing, incoming materials and regulatory samples.
• Perform additional tasks as needed by supervisor.

Skills

Environmental monitoring

GMP compliance

Laboratory testing

Training & coaching

QA/CAPA processes

Education

Bachelor's degree in Microbiology or related

Job description

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.