Senior QC Leader, Biotech | ISO13485 & qPCR

Mirxes; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

MiRXES is seeking a QC Supervisor to join the Quality team in ensuring strict QC across manufacturing stages and detailed record-keeping. You will oversee raw materials, intermediates, and finished goods, while driving investigations of nonconformances and corrective actions.

You will support validation and stability studies and ensure all activities align with ISO13485 and regulatory requirements, with emphasis on traceability and proper documentation practices.

Qualifications

• Diploma or degree in biotechnology, biochemistry or life sciences.
• qPCR knowledge and ability to operate qPCR instrumentation.
• Experience in QC or quality control in manufacturing preferred.

Responsibilities

• Manage team performance, including training and competency assessments.
• Supervise QC Specialists and Technicians for routine QC operations.
• Plan and schedule daily QC routines and ad hoc testing.
• Oversee QC lab housekeeping, equipment maintenance, and inventory tracking.
• Perform routine QC testing of raw materials, in-process materials and finished goods.
• Evaluate data, draft/review QC reports and highlight deviations.
• Perform trend analysis using SPC to identify process anomalies.
• Troubleshoot QC failures and raise nonconformances, determine root causes.
• Support validation and stability studies and ensure ISO13485 compliance.

Skills

qPCR knowledge

Laboratory testing

Documentation practices

People management

Organizational skills

Time management

Independent worker

Education

Diploma/Bachelor/Master in Biotechnology / Biochemical / Biochemistry / Analytical Chemistry / Molecular Biology

Job description

MiRXES is seeking a QC Supervisor to join the Quality team in ensuring strict QC across manufacturing stages and detailed record-keeping. You will oversee raw materials, intermediates, and finished goods, while driving investigations of nonconformances and corrective actions.

You will support validation and stability studies and ensure all activities align with ISO13485 and regulatory requirements, with emphasis on traceability and proper documentation practices.