Senior QC Lead - Biotech Diagnostics (GMP/ISO 13485)

Mirxes; Singapore; On-site; SGD 50,000 - 69,000; Full time

Job summary

MiRXES, a Singapore-headquartered molecular diagnostics company, is seeking a QC Supervisor to join our Quality team in Singapore. You will support day-to-day QC operations, inspect raw materials, intermediates, in-process and finished goods, and oversee nonconformances with appropriate CAPA actions.

You will manage QC staff, plan daily QC activities, ensure traceability and documentation in line with ISO13485 and GMP requirements, and contribute to continuous improvement of QC workflows.

Qualifications

• Diploma/Bachelor/Master in Life Science or engineering related fields.
• Hands-on qPCR knowledge and operation of qPCR machines.
• Experience in quality control within lab settings and ISO13485/GMP is a plus.
• Able to train and manage QC staff and work with cross-functional teams.

Responsibilities

• Manage team performance, including training, competency assessments and ensuring the technical proficiency of QC staff.
• Supervise QC Specialists and Technicians to ensure smooth execution of routine QC operations.
• Plan and schedule daily QC routine and ad hoc testing.
• Oversee QC lab housekeeping, including cleanliness, equipment maintenance, document archival, and reagent inventory tracking.
• Perform routine QC testing of raw materials, in-process materials and finished goods.
• Evaluate data, draft and/or review QC reports, highlighting deviations from standard operating procedures.
• Perform trend analysis and utilize Statistical Process Control (SPC) tools to identify process anomalies and prevent failures.
• Troubleshoot QC failures and raise nonconformance reports when needed. Investigate nonconformances to determine root causes.
• Support validation and stability studies for lab development and diagnostic products as needed.
• Ensure all laboratory activities and documentation are complaint with ISO13485 and relevant regulatory requirements.
• Draft and update QC work instructions and contribute to the continuous improvement of workflow procedures and processes.
• Apply good documentation practices on all records for better traceability, transparency, and the purpose of auditing.
• Perform any other duties as assigned.

Skills

qPCR knowledge

Lab testing experience

Quality control

Team management

Documentation practices

Education

Bachelor/Master in Life Science

Tools

qPCR machine

Laboratory equipment

Job description

MiRXES, a Singapore-headquartered molecular diagnostics company, is seeking a QC Supervisor to join our Quality team in Singapore. You will support day-to-day QC operations, inspect raw materials, intermediates, in-process and finished goods, and oversee nonconformances with appropriate CAPA actions.

You will manage QC staff, plan daily QC activities, ensure traceability and documentation in line with ISO13485 and GMP requirements, and contribute to continuous improvement of QC workflows.