Laboratory Quality Assurance Officer at The African Medical Centre of Excellence (AMCE)

Job Purpose

• The Laboratory Quality Assurance Officer will ensure the highest standards of quality, accuracy, and compliance across all laboratory operations. This role involves implementing and monitoring quality management systems, conducting audits, managing documentation, and ensuring adherence to regulatory requirements.
• The officer will work closely with laboratory managers, technicians, and clinical staff to maintain accreditation, improve processes, and support safe, reliable, and effective diagnostic services.

Key Accountabilities/Responsibilities

Quality System Management

• Develop, implement, and maintain the laboratory 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 (CAPA) processes.

Compliance and Accreditation

• Ensure laboratory compliance with local regulations (NAFDAC, MLSCN, NNRA) and international standards (ISO, CLIA).
• Prepare for and support external audits and inspections.
• Monitor changes in regulatory requirements and implement updates.

Process Improvement and Training

• Identify opportunities for process improvement and risk reduction.
• Support in updating laboratory staff on quality procedures, documentation, and compliance.
• Participate in quality meetings and report on key performance indicators.

Incident and Non-Conformance Management

• Investigate laboratory incidents, deviations, and non-conformances.
• Ensure timely reporting and resolution of quality issues.
• Maintain records of incidents and corrective actions.

Data and Record Management

• Manage quality-related data, including proficiency testing results, equipment calibration, and validation records.
• Ensure confidentiality, integrity, and accessibility of quality documentation.

Qualifications

• Bachelor’s degree in medical laboratory science or biomedical sciences.
• Certification in Quality Management (e.g., CQA, ISO 15189 Lead Auditor) is highly desirable.
• Minimum of 3 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, CLSI).
• 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.