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: Helios (Onsite)
Job Summary
Reporting to the Director, Lab & Services (primary), and the head of quality (secondary), the Quality Assurance position in Precision Genomics, is primarily responsible for the quality management system, its associated processes and the laboratory's accreditation.
Roles and Responsibilities
Quality System Management
- Maintenance and upkeep of QMS
- Monitoring of QMS processes to ensure compliance to standards and corporate requirements
- Monitoring of processes for upkeep of QMS health
- Collaborate with Process Owners to set-up/improve processes to achieve compliance and excellence
- Cross functional collaboration to ensure successful implementation / revision of processes
- Improvement / enhancements to existing processes
- Document control
- Drafting and reviewing of documents
- Arranges and prepare for management review
- Conduct / facilitate internal audits
- Assist in 1st, 2nd and 3rd party audits
- Conduct / facilitate 2nd and 3rd party audits
- Assist in audit actions
- Lead work needed for closure of audit items/actions
- Facilitate / assist in risk management activities
- Lead / supervise the actions for quality events
- Upkeep / Facilitate / raise of quality events
- Execution of actions resultant from quality events
- Conduct training on QA and/or Operational Compliance processes
- Assist in vendor evaluation/re-evaluation
- Facilitate / assist in validation activities
- Assist in design / technology transfer
- Monitoring of quality assurance and/or operational compliance metrics
- Reporting of quality assurance and/or operational compliance metrics
- Foster a culture of quality awareness and continuous improvement throughout the organization
Clinical Laboratory
- Review of proficiency testing results, ensure the appropriate documentation and CAPA is performed
- Preparation and compilation of quality metrics for reporting purposes on a monthly and quarterly basis
- Continuous upkeep of regulatory and proficiency test requirements
- Ensure key accreditations (HCSA, CAP) for the laboratory are achieved and maintained
- Align with laboratory operations and management to ensure requirements are met for accreditation
- Reporting to laboratory management on quality metrics and operational quality assurance.
Leadership
- Quality assurance strategy
- Develop quality assurance and operational compliance metrics in alignment with leadership
Note: This is a dual reporting role, Director, Lab & Services (primary), and the head of quality (secondary).
Desired Skills and Competencies
- Diploma / Degree in related Science discipline.
- Results orientated, with a high level of integrity and dependability with a strong sense of urgency.
- Good collaboration spirit and willingness to work cross function and entity within the Mirxes group of companies.
- Prior experience in achieving and maintaining a HCSA-licensed laboratory with CAP accreditation.
- Prior Clinical laboratory QA experience is desired
This position is based in Singapore.
We appreciate your interest in the above-mentioned position, however, only shortlisted candidates will be contacted.
