Job Purpose
The Laboratory Quality Assurance Officer will ensure the highest standards of quality, accuracy, and compliance across all diagnostics operations.
This role involves implementing and monitoring quality management systems, conducting audits, managing documentation, and ensuring adherence to regulatory requirements.
Job Responsibilities
Develop, implement, and maintain the quality management system in line with applicable regulatory standards.
Oversee documentation control, including SOPs, policies, and quality records.
Coordinate internal audits and manage corrective and preventive action processes.
Ensure compliance with local regulations (HEFAMAA, MLSCN, and NNRA) and ISO 15189:2022 requirements.
Prepare for and support external audits and inspections.
Monitor changes in regulatory requirements and implement updates.
Identify opportunities for process improvement and risk reduction.
Support in updating staff on quality procedures, documentation, and compliance.
Participate in quality meetings and report on key performance indicators.
Investigate incidents, deviations, and non-conformances.
Ensure timely reporting and resolution of quality issues.
Maintain records of incidents and corrective actions.
Manage quality-related data, including proficiency testing results, equipment calibration, and validation records.
Ensure confidentiality, integrity, and accessibility of quality documentation.
Requirements
Bachelor's Degree in medical laboratory science or biological sciences.
Certification in Quality Management will be an added advantage
Minimum of 2 years' experience in a laboratory quality assurance role within a healthcare or diagnostic setting.
Experience with laboratory accreditation processes is essential.
Experience:
Strong knowledge of quality standards (ISO 15189, ISO 9001).
Experience conducting internal audits and managing CAPA.
Excellent attention to detail and organizational skills.
Proficient in data analysis and report writing.
Strong communication and training skills.
Ability to work collaboratively in a multidisciplinary environment.