Laboratory QA/QC Manager at Centre for Infectious Disease Research in Zambia

Laboratory QA/QC Manager Ref No. QM/LB/18/04/19

Reports to Laboratory Director. Establishing, coordinating, and monitoring the laboratory quality management system; working closely with Laboratory Director and management to plan, schedule, and implement Quality Assurance related activities to ensure that all services and results from CIDRZ Central Laboratory meet international standards

Main duties

• Prepares new SOPs together with intended users, for all tests and procedures performed at the Laboratory.
• Coordinates reviews and updates of all QMS documentation annually and or as needed to ensure the continued relevance to the quality management system
• Ensures that all laboratory staff are trained and certified on implementation of the laboratory policies and procedures, including but not limited to, processing of tests, reporting of results, quality control and general laboratory safety.
• Schedules competency assessments and monitor documentation for all staff to ensure they are competent to perform their specific duties.
• Identifies QMS training needs for staff and make recommendations to the Laboratory Director.
• Carries out Quality assurance training of all staff to ensure understanding and appreciation of its importance, so as to provide quality service and generate quality results.
• Manages the receipt, processing, analysis and reporting of external proficiency testing specimens for all External Quality Assurance surveys.
• Carries out weekly reviews of QC performance by staff and ensure documentation of all data, including all corrective and preventative action.
• Regularly reviews all QC data logs/charts, with management to detect deviations, verify documented corrective actions and make recommendations for improvement.
• Schedules and carries out internal audits to ensure all processes are performed according to the documented quality management system and international standards.
• Monitors and document corrective action and/or preventative maintenance on audit findings.
• Prepares the laboratory for external audits, initiate and implement corrective action/preventative action on findings and document accordingly.
• Develops and Monitors the agreed quality indicators [including TAT] in conjunction with laboratory management as stated in the annual Quality
• Generates monthly quality assurance reports for the Laboratory Director and ensure corrective action and preventative action mapped out and implemented.

Qualifications

•  Bachelors/Honors Degree in Biomedical sciences
• 7 years’ experience as Biomedical Scientist with at least 4 years working in a medical laboratory with a competent QMS programs
• Knowledge and implementation of ISO 15189 standard and GCLP guidelines is required. Knowledge of other standards e.g. CAP, ISO 17025 also applies
• Prior knowledge and work with NIH and DAIDS Network research protocols is required.
• Current registration with Health Professions Council of Zambia is a must
• Experience with internal and proven records of external auditing in Medical Laboratories and Master of Science Biomedical sciences will be an added advantage.

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