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.
The ideal candidate will have a strong background in quality assurance (QA) within the medical laboratory field, with a minimum of three years of relevant experience. The Medical Laboratory QA Executive will be responsible for ensuring compliance with quality standards, implementing quality control measures, and driving continuous improvement initiatives. Familiarity with accreditation requirements such as CAP or ISO 15189 is essential for this role.
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.
- Proficiency in using quality tools and software applications for data analysis and reporting, including MediaLab, Microsoft 365, SharePoint.