QC Senior Scientist (Metrology)

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

Participate in the start-up operations of the SG QC lab operations needs in terms of departmental goals and objectives:

• Instrument/Equipment & Computer System Setup - Support user configuration, system testing, and SOP generation for QC instruments with OPS/Metrology lead.
• Instrument/Equipment Qualification Strategy - Plan and strategize Instrument/Equipment qualification strategy with OPS/Metrology Lead.

Routine GMP Phase:

• Responsible for the implementation and continual improvement of the QC metrology qualification/computer system qualification processes.
• Act as on-site SME for metrology or computer system qualification root cause analysis or CAPA.
• Provides key input and recommendation of data review or investigation process. Serves as lead for client discussions regarding project quality or investigations related to studies.
• Proficient in microbiological, protein-based assays, including bioburden, endotoxin, HPLC, CE electrophoresis, ELISA, PCR and/or potency analytical methods.
• Use proficiently advanced laboratory equipment, such as, but not limited to HPLC, CE, PCR, plate readers, etc.
• Effective multi-tasking skills and time management required.
• Able to evaluate technical data and record data accurately and legibly.
• Able to work with QA in coordination towards adhering and supporting Data Integrity compliance towards work and review
• Provide training in the areas of technical expertise and compliance issues relevant to the analytical instrument.
• Prepare SOP, protocols, final reports, investigations, and deviations as needed.
• Conduct timely review of equipment calibration/maintenance reports and data appropriately.
• Maintain/review laboratory notebooks and worksheets for QC equipment/software as required
• Able to develop/align QC equipment and software systems laboratory SOPs with global corporate standards.
• Work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Any other tasks or projects deemed necessary by the superior to support the QC department.

Requirement :

• Diploma / Bachelor’s degree or above in Chemistry, Microbiology, Biochemistry, or a related scientific discipline.
• 5 - 10 years of relevant experience in quality control, quality assurance, auditing, compliance or a related GMP‑regulated environment, with depth and breadth appropriate to the role.
• Strong communication skills, both written and verbal, and outstanding interpersonal skills.
• Strong skills in scientific and technical writing.
• Good software operation skills, intermediate to advanced level in Microsoft Word, Excel, PowerPoint.
• Critical thinking, scientific reasoning and problem-solving skills.
• Familiar with Computerized System related regulatory, such as CFR21 Part11, EU GMP Annex 11, etc.
• Familiar with analytical instrument/equipment qualification, calibration, PM and repair, such as UPLC, HPLC, CE and CIEF etc.

Would be a plus if having the following working experiences:

• Analytical instrument/equipment operation and sample testing.
• Handling deviations, change control, and responding to audit questions.
• Operation of instrument software, including but not limited to LES, ELN, Cispro, Empower, SoftMax Pro,, EndoScan-V, Lab-X., and LIMS for Lab Admin role.