Senior QC Specialist (Biotechnology)

Mirxes; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

MiRXES in Singapore is seeking a QC Supervisor to join the Quality team. You will oversee day-to-day QC operations, supervise staff, and ensure compliance with ISO13485 and regulatory requirements.

Responsibilities include material and finished product testing, data review, SPC analysis, nonconformance investigations, and supporting validation activities. Desired candidate has 4–5 years in QC within medical device manufacturing and GMP/ISO13485 experience, with qPCR knowledge.

Qualifications

• Diploma/Bachelor/Master in Biotechnology, Biochemical, Biochemistry, Analytical Chemistry, Molecular Biology/Life Science related courses.
• qPCR knowledge and experience with qPCR machines.
• Experience with laboratory testing and QC of assays-based workflows is advantageous.
• Able to work independently with minimal supervision and with others.
• Excellent organizational and time management skills.
• 4–5 years of relevant experience in quality control; medical device manufacturing experience preferred.
• GMP and ISO 13485 experience would be beneficial.

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, documentation 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 SPC tools to identify process anomalies and prevent failures.
• Troubleshoot QC failures and raise nonconformance reports; investigate root causes.
• Support validation and stability studies for lab development and diagnostic products as needed.
• Ensure all lab activities and documentation comply with ISO13485 and regulatory requirements.
• Draft and update QC work instructions and contribute to continuous improvement of workflows.
• Apply good documentation practices on all records for traceability and auditing.
• Perform any other duties as assigned.

Skills

qPCR knowledge

Laboratory testing

Documentation & record-keeping

People management

Analytical thinking

Education

Biotechnology/Life Sciences degree (Diploma/Bachelor/Master)

Job description

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 Summary

QC Supervisor will work as part of the Quality team to support the QC of day-to-day operations and maintain detailed records for all the tasks assigned. The individual will inspect the products in different stages of manufacturing process such as incoming raw materials, intermediates, in-process and finished good. The individual will also participate in the investigation of nonconforming products and follow-up with the actions that arises from these inspections.

Roles and 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.

Desired Skills and Competencies:

• Diploma/Bachelor/ Master of Science/ Engineering or equivalent in Biotechnology, Biochemical, Biochemistry, Analytical Chemistry, Molecular Biology/ Life Science related courses.
• Have qPCR knowledge and experience in using qPCR machine.
• Familiar with the basic laboratory procedures. Relevant experience with laboratory testing, and QC of assays-based workflow will be an advantage.
• Able to work independently with minimal supervision and with others within and outside his/her function.
• Excellent organizational and time management skills.
• High degree of initiative and ownership.
• Possess a positive and willing-to-learn attitude.
• Good logical thinking and reasoning ability.
• Good Documentation Practices and ability to write protocols and procedures
• People management experience including training, development and mentoring/coaching of technical staff would be an added advantage.
• 4-5 years of relevant experience in quality control and preferably in medical device manufacturing industry.
• GMP and/or ISO 13485 experience would be an added advantage.

This position is based in Singapore.

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