Quality Control Specialist

Overview

MiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection and provide insights for better patient care by harnessing the power of microRNA to augment traditional testing. Our vision is to be the world’s leading developer and provider of accurate, actionable, and affordable microRNA-powered diagnostic tests.

Job Location: 2 Tukang Innovation Grove, JTC MedTech Hub, Singapore

The QC Specialist will work as part of the Quality team, supporting day-to-day QC operations and maintaining accurate and detailed records of all the assigned tasks. This role involves inspecting products at various stages of the manufacturing process, including incoming raw materials, intermediates, in-process materials and finished goods. This person will also participate in investigations of nonconforming products and assist in implementing corrective actions arising from these inspections.

• Perform routine QC testing of incoming raw materials, in-process materials and finished goods.
• Plan and schedule daily routine and ad hoc QC runs assigned by line manager.
• Evaluate data and generate reports, highlighting any deviations from standard operating procedures (SOPs).
• Raise nonconformance for failures observed during QC runs.
• Support troubleshooting and investigation of nonconformance to determine root causes.
• Draft and revise QC work instructions as required.
• Support validation and stability studies for lab development and Diagnostic products, when necessary.
• Perform general laboratory support activities, including housekeeping, equipment maintenance, document archival, and inventory tracking of laboratory reagents, etc.
• Contribute to the continuous improvement of laboratory procedures and processes to ensure compliance with GMP requirements.
• Apply Good Documentation Practices (GDP) to all records to ensure traceability, transparency, and audit readiness.
• The tasks and responsibilities listed are essential to the role, however, reasonable accommodations may be made to support additional responsibilities based on evolving business needs.

• Degree/ Diploma in Biomedical Science, Biotechnology, Molecular Biology, Biochemistry, Life Science related courses or equivalent.
• Knowledge and hands-on experience with qPCR, including operation of qPCR machines will be an advantage.
• Proficient in using standard laboratory equipment such as pipettes, centrifuges, etc.
• Familiar with basic laboratory procedures; experience in assay-based workflows and QC testing is an advantage.
• Able to work independently with minimal supervision, as well as collaboratively with cross-functional teams.
• Excellent organizational and time management skills.
• Demonstrate a high degree of initiative and ownership.
• Possess a positive, proactive and willing-to-learn attitude.
• Strong interpersonal and communication skills.
• Basic computer competency, including proficiency in Microsoft Office applications.
• 2-3 years of relevant experience in quality control, preferably within the medical device manufacturing industry.
• Good understanding of Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP) is preferred.

This position is based in Singapore.

We appreciate your interest in the above-mentioned position, however, only shortlisted candidates will be contacted.