QA Executive

3 days ago


Singapore GENE SOLUTIONS SGP PTE. LTD. Full time

**Position Overview**

Gene Solutions provides early cancer screening and tumor profiling tests to guide treatment decisions, using liquid biopsy and NGS techniques. As we continue to expand our operations, we are seeking a highly motivated and experienced Laboratory QA Executive to join our team.

**Responsibilities**

**1.**Quality Assurance and Compliance**:

- Work with laboratory directory to maintain the quality management system (QMS) to ensure compliance with regulatory requirements, industry standards, and accreditation guidelines such as CAP or ISO 15189.
- Chair monthly QA review meetings to monitor quality trends, and identify areas for improvement.
- Monitor and evaluate laboratory processes, workflows, and documentation to ensure adherence to QMS.
- Coordinate external audits and inspections by regulatory bodies or accreditation agencies, ensuring preparedness and compliance.
- Investigate and address non-conformities, incidents, and customer complaints, implementing corrective and preventive actions (CAPA) as necessary.

**2.**Quality Control**:

- Maintain quality control processes to ensure accuracy, reliability, and precision of laboratory testing.
- Develop and maintain quality control documentation, including SOPs, protocols, and quality control records.
- Monitor and review quality control data, identifying trends, deviations, and opportunities for process improvement.
- Collaborate with laboratory manager to provide training and guidance on quality control practices and troubleshooting procedures.
- Other duties as required.

**Qualifications**
- Bachelor's degree in Molecular Biology, Laboratory Science, Biotechnology, Life Science or a related field.
- Minimum of three years of experience in quality assurance or quality control within a medical laboratory setting.
- Strong knowledge of quality management systems (QMS), HCSA licensing and CAP accreditation requirements.
- Excellent understanding of laboratory processes, workflows, and regulatory guidelines.
- Experience in conducting internal audits, managing non-conformities, and implementing CAPA processes.
- Strong analytical and problem-solving skills, with attention to detail and accuracy.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.


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