Compliance & QA Officer

5 days ago

Singapore MiRXES Pte Ltd. Full time

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**:
**Roles and Responsibilities**
- Assist Operations Manager in managing laboratory ’s day to day operation and administrative role, with focus on safety, quality, productivity and compliance.
- Interpret, build upon, and comply with company quality assurance standards
- Carefully maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions
- Document quality assurance activities with internal reporting and audits
- Develop new standards for production and design, with improvements as needed, and create testing protocols for implementation across all service lines
- Identify training needs and take action to ensure company-wide compliance
- Assist for inventory management, quality assurance activities and updating laboratory protocols, investigation, and documentation of adverse incidents.
- Assist in develop, implement, and continuously improve section’s operating procedures in accordance with technical and operational requirements.
- Participate in assisting to develop, implement and continuously improve lab’s quality, regulatory and safety standards to ensure compliance with all applicable local and global regulatory requirement, including but not limited to PHMC, ISO15189, CAP.
- Assist team in the development, validation and implementation of new workflow.
- Any additional duties as assigned by reporting officer.
**Desired Skills and Competencies**
- Minimum Bachelor’s degree in Biomedical Science, Medical Laboratory Science or equivalent qualification
- Minimum 3 years laboratory operation on compliance and QA experience preferred
- Keen interest to learn and genuine passion, demonstrated work
- Strong team player with positive work attitude, analytical minded, result-oriented, good communication and interpersonal skills
- Strong computer competence, including database management
- Knowledge of quality assurance terminology, methods, and tools
- Analytical, problem-solving, and decision-making skills
- Demonstrated knowledge of testing best practices, version control practices and defect management practices

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