Senior QC Scientist - Metrology & Data Integrity Lead

WuXi Biologics; Singapore; On-site; SGD 60,000 - 110,000; Full time

Job summary

WuXi Biologics in Singapore seeks a senior QC/Metrology Specialist to support startup SG QC lab operations and ensure data integrity in GMP environments. You will lead instrument qualification strategies, SOP development, and collaboration with QA to uphold regulatory standards.

The role requires 5–10 years in quality control/assurance, strong technical writing, and hands-on experience with analytical instruments (UPLC/HPLC/CE), lab software, and regulatory CFR21 Part 11 compliance.

Qualifications

• Diploma or Bachelor’s degree in Chemistry, Microbiology, Biochemistry, or related discipline.
• 5–10 years in quality control/quality assurance/audit in GMP-regulated environment.
• Strong written and verbal communication; outstanding interpersonal skills.
• Strong scientific writing skills.
• Proficient in MS Word/Excel/PowerPoint; data integrity and regulatory compliance.
• Familiar with CFR21 Part11 and EU GMP Annex 11.
• Familiar with instrument qualification and calibration (UPLC/HPLC/CE).

Responsibilities

• Implement and continually improve QC metrology qualification and computer system qualification processes.
• Act as on-site SME for metrology or computer system qualification root cause analysis or CAPA.
• Provide input on data review or investigations; lead client discussions on quality.
• Perform analyses of microbiological and protein-based methods (bioburden, endotoxin, HPLC, CE, ELISA, PCR).
• Operate advanced lab equipment (HPLC, CE, PCR, plate readers).
• Multi-task effectively and manage time.
• Coordinate with QA to uphold Data Integrity compliance.
• Provide training on technical expertise and compliance issues.
• Prepare SOPs, protocols, final reports, investigations, and deviations.
• Review equipment calibration/maintenance reports and data.
• Maintain notebooks and SOPs for QC equipment/software.
• Develop/align QC equipment and software SOPs with global standards.
• Perform routine tasks per written procedures and flag deviations.
• Support QC department with additional tasks as needed.

Skills

QC / Quality control

Analytical thinking

Scientific reasoning

Communication skills

Education

Diploma / Bachelor’s degree in Chemistry, Microbiology, Biochemistry, or related scientific discipline

Tools

Microsoft Word

Excel

PowerPoint

ELN

Cispro

Empower

SoftMax Pro

EndoScan-V

Lab-X

CIEF

LES

LIMS

Job description

WuXi Biologics in Singapore seeks a senior QC/Metrology Specialist to support startup SG QC lab operations and ensure data integrity in GMP environments. You will lead instrument qualification strategies, SOP development, and collaboration with QA to uphold regulatory standards.

The role requires 5–10 years in quality control/assurance, strong technical writing, and hands-on experience with analytical instruments (UPLC/HPLC/CE), lab software, and regulatory CFR21 Part 11 compliance.