QC Scientist - Microbiology

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 52,000 - 82,000; Full time

Job summary

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking a Scientist II to join the Quality Control (Microbiology) team in Singapore. You will perform microbiological testing on materials and finished products to ensure compliance with regulatory and internal standards, including release testing and monitoring of utilities.

The role emphasizes adherence to ALCOA data principles, instrument qualification support, and the ability to work independently to meet tight timelines in a fast-changing environment.

Qualifications

• Bachelor Degree in Microbiology, Biology, Biotechnology, Life Sciences or equivalent
• 2-3 years of experience in pharmaceutical or medical devices industry; lab experience preferred
• Familiar with PICS, ICH, Singapore HSA, FDA, EMA, NMPA, WHO guidelines and USP, Eur.P, ChP pharmacopoeias
• GMP manufacturing knowledge is a plus
• Basic lab skills: pipetting, glassware management, lab safety
• Proficiency with MS Office tools (Word, Excel, PowerPoint)
• Ability to work independently and meet critical timelines
• Strong attention to detail and adaptability to changing environment
• Effective interpersonal communication at all levels

Responsibilities

• Perform QC microbiological testing of materials and products under cGMP conditions
• Monitor facility utilities and perform testing for release or stability studies
• Support instrument and equipment qualification
• Coordinate calibration and maintenance of laboratory instruments
• Assist aseptic process simulations and method transfer/validation activities
• Maintain laboratory documentation in compliance with ALCOA principles
• Manage microbiological inventory for sampling and testing
• Ensure adherence to quality and regulatory standards

Skills

Attention to detail

Independent worker

Interpersonal skills

Meet deadlines

Education

Bachelor Degree in Microbiology/Biology/Biotechnology/Life Sciences

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

About the role

The Scientist II position is an integral member of the Quality Control (Microbiology) team. In this role, you are expected to perform the work required to ensure product quality is maintained at standard set forth by regulatory agencies, clients and corporate requirements. Some responsibilities include utilities/cleanroom monitoring, completing incoming, in-process, and final release testing of various products manufactured or received in the Microbiology Laboratory.

Key responsibilities

• Perform quality control microbiological testing of raw materials, incoming goods, intermediates, in-process, drug substance, and/or finished products under cGMP conditions for QC release or part of stability studies
• Perform monitoring and testing for the facility and utilities system
• Support instrument qualification
• Support equipment qualification e.g., controlled temperature units, isolator, biosafety cabinets
• Perform and coordinate calibration, preventative maintenance and repairs of laboratory instruments/equipment
• Support aseptic process simulations
• Support microbiological method transfer/development/validation/verification/suitability
• Perform periodic review for laboratory documents
• Manage microbiological inventory required for sampling and testing
• Ensure adherence to ALCOA principles for managing laboratory data

About you

• Bachelor Degree in Microbiology, Biology, Biotechnology, Life Sciences or equivalent
• 2-3 years of experience in the pharmaceutical or medical devices industry, with experience on working in a laboratory environment preferred, but fresh graduates with laboratory experience during tertiary studies is acceptable
• Familiar with PICS, ICH, Singapore HSA, FDA, EMA, NMPA, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias
• Preferred to have knowledge on GMP manufacturing
• Basic laboratory skills such as pipetting, glassware management and laboratory safety
• Basic proficiencies in digital literacies such as Microsoft Word, Excel, PowerPoint
• Ability to work independently and follow critical timelines
• Ability to adapt to a changing work environment
• Effective interpersonal skills at all internal and external levels
• Excellent attention to details