QC Microbiologist

WuXi XDC; Singapore; On-site; SGD 50,000 - 73,000; Full time

Job summary

WuXi XDC in Singapore seeks a qualified professional to perform quality control microbiological testing of raw materials, in-process, and final products under cGMP conditions for QC release and stability studies.

The role supports equipment qualification, calibration, and maintenance of lab instruments, and contributes to aseptic simulations and method transfers. Strong cGMP knowledge and data integrity are essential.

Qualifications

• Bachelor’s degree or higher in biological sciences or related field with minimum 3 years of experience.
• GMP laboratory experience preferred.
• Strong knowledge of cGMP compliance and a quality mindset.

Responsibilities

• Perform quality control microbiological testing of raw materials, in-process, intermediates, drug substances and finished products under cGMP conditions for QC release or stability studies.
• Monitor and test the facility and utilities systems.
• Support equipment qualification, calibration, preventative maintenance and repairs for laboratory instruments.
• Assist aseptic process simulations and microbiological method transfer/development/validation/verification/suitability.
• Maintain laboratory documents and ensure ALCOA data integrity.
• Maintain training records and 5S housekeeping.
• Escalate investigations, accidents, near misses and policy breaches in a timely manner.
• Report to and assist the Manager as required.

Skills

Quality control

Microbiology

GMP

Laboratory testing

Education

Bachelor’s degree in Biological Sciences or related field

Job description

• To 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
• To perform monitoring and testing for the facility and utilities system
• To support equipment qualification e.g., controlled temperature units, isolator, biosafety cabinets
• To perform and coordinate calibration, preventative maintenance and repairs or laboratory instruments/equipment
• To support aseptic process simulations
• To support microbiological method transfer/development/validation/verification/suitability
• To perform periodic review for laboratory documents
• To manage microbiological inventory required for sampling and testing
• To ensure adherence to ALCOA principles for managing laboratory data
• To adhere to site/job role training plan, and maintain individual training records
• To maintain laboratory housekeeping using 5S approach
• Ensure timely escalation of investigations accidents, near misses and breaches of policies
• To carry out tasks required by the reporting Manager

Qualifications:

• Bachelor’s degree or higher in biological sciences, biotechnology, pharmaceutical sciences or equivalent with min 3 years of working experience
• Prior experience in working in a GMP laboratory preferred
• In-depth knowledge of cGMP compliance principles and a strong quality-focused mindset.