Regulatory & Scientific Affairs Officer

• Ensure compliance with laboratory accreditation, regulatory standards and information management policies by providing guidance to staff to ensure that quality policies, processes and procedures are established, current and adhered to by all Clinical staff.
• Oversee internal audit processes, external assessments, proficiency testing programs; document control systems; competency assessment; training and other quality processes.
• Recommend best practices to maintain and improve project outcomes or laboratory functions; facilitates laboratory improvement activities.
• Analyze data, identify trends, monitor prevention and correction of quality deviations, and develop reports for management utilizing technical knowledge and experience across all departments.
• Monitor, together with the Data Scientist, customer satisfaction and performance metrics.
• Identify and report quality issues and problems across departments to management with recommendations for resolutions.
• Work with RevnaBio team to align quality practices, including data analysis, monitoring trends, prevention, corrections and continuous quality improvement.

• Ensure that laboratory personnel and instrumentation meet performance standards.
• Ensure that operational processes meet organizational requirements through the application of workflow processes or the development of method validation and performance verification processes and procedures.
• Ensure that there is an effective system to control and manage documents and records.
• Develop and ensure that processes and procedures are in place for detecting and managing nonconforming events, and performing internal audits and external assessments
• Develop and ensure mechanisms for continuous quality improvement.
• Comply with regulations and guidelines governing laboratory testing, ensuring staff compliance and evaluating method validation and performance verification results.

• Demonstrate knowledge and skills related to the scientific and technical components of laboratory testing in order to oversee the policies, processes and procedures related to QA activities.

• Deploy formal written and oral communication strategies, display active listening skills, and demonstrate comprehension of written documents and directions.
• Ensure professionalism and compliance in communication and prepare professional written reports and oral presentations.

• Uphold professional and scientific ethics.
• Serve as a role model for integrity and ethical conduct.

• Bachelor’s degree in biological science or related field (e.g., medical laboratory science, microbiology, biochemistry, molecular biology, immunology, quality management).
• Minimum of 3 years of recent related work experience in a certified (e.g., FDA, HEFRA, ISO, EPA) clinical, public health or environmental laboratory.

• Working knowledge of quality management systems and quality improvement tools and techniques such as Six Sigma or Lean.
• Working knowledge of accreditation standards, practices and guidelines sufficient to advise and guide laboratory managers and supervisors as they implement and maintain accreditation.
• Working knowledge of computer and analytical software programs sufficient for evaluation of electronic data, data interpretation, and report development.
• A strong understanding of the principles, practices, and techniques of the various analytical areas of the laboratory and other departments
• Excellent organization skills allowing the coordination of multi-faceted QA activities.
• Ability to analyze and interpret written information and scientific data, compare against established requirements, identify potential discrepancies, and make suggestions for improvement.
• Ability to conduct and report quality assurance audits and reviews to determine compliance status and recommend corrective action plans.

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