Quality Assurance Officer

About the Role

The Quality Assurance Officer is responsible for upholding superior standards of accuracy, reliability, and regulatory compliance within diagnostic laboratory operations. This position entails the implementation and maintenance of an effective quality management system, overseeing audits, managing documentation, and ensuring continuous alignment with regulatory mandates.

Key Duties and Responsibilities

• Establish, implement, and sustain a quality management framework that aligns with relevant regulatory standards.
• Manage control over documentation, including standard operating procedures (SOPs), policies, and quality records.
• Organize and conduct internal audits while overseeing corrective and preventive actions.
• Maintain compliance with local regulatory bodies such as HEFAMAA, MLSCN, NNRA, and adhere to ISO 15189:2022 standards.
• Facilitate preparation for external audits and inspections, supporting audit activities as needed.
• Stay informed on regulatory updates and apply necessary changes within the quality systems.
• Identify and implement process improvements to minimize risks.
• Help train and update staff regarding quality procedures, documentation standards, and compliance requirements.
• Participate in quality meetings, providing reports on key performance indicators.
• Investigate any incidents, deviations, or non-compliances and ensure timely resolution and reporting.
• Maintain comprehensive records of quality incidents and corrective measures taken.
• Administer quality-related data management including proficiency testing results, calibration records, and validation documentation.
• Guarantee confidentiality, integrity, and appropriate access to all quality management documents.

Qualifications and Experience

• Bachelor's degree in Medical Laboratory Science or Biological Sciences is required.
• Certification in Quality Management is advantageous.
• At least 2 years of professional experience in a laboratory quality assurance role within healthcare or diagnostics.
• Proven experience in laboratory accreditation procedures is essential.

Required Skills and Competencies

• In-depth knowledge of quality standards, including ISO 15189 and ISO 9001.
• Experienced in conducting internal audits and handling corrective and preventive actions (CAPA).
• Exceptional attention to detail paired with strong organizational abilities.
• Competency in data analysis and technical report writing.
• Effective communication and training capabilities.
• Ability to collaborate effectively within a multidisciplinary team environment.