Key Responsibilities:
Oversee a quality control program appropriate for tests performed in the DLSP laboratories
Ensures delivery against QA department goals and objectives i.e. Meeting commitment and Coordinating overall quality assurance schedules.
Tie breaker- performs test; implementing statistics and process control tools; maintaining effective compliance and corrective actions procedures.
Responsible and accountable of flagging the timing of interdepartmental deliverables and quality of their output i.e. time schedules and time plans or layout
Implement improvements to laboratory testing procedures to improve efficiency, resource utilization, decrease turnaround time, etc., utilizing new and established laboratory policies and procedures.
Work with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation.
In consultation with laboratory management, stop further processing of any work until the quality problem has been corrected
Develop, perform, and manage an audit program that encompasses all phases of laboratory practices and field sample collection and provide assurance that, documentation, and record-keeping requirements are met.
Perform scheduled and unscheduled checks on bench scientists.
Administer the proficiency testing and EQA.
Maintain current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
Maintain current and accurate records of all personnel qualifications, certifications and contact information.
Review, track and communicate information regarding process variations and quality control samples as required by laboratory quality assurance procedures.
Check validation systems for all pieces of equipment to ensure maximal function (service schedules, daily panel runs, etc)
Train/supervise training of laboratory staff and document such trainings.
Review and maintain all laboratory SOPs
Review test results and reports for accuracy, completeness and compliance to requirements to ensure that quality assurance standards and regulatory requirements are met.
Maintain familiarity with laboratory procedures in order to effectively perform laboratory quality assurance functions.
Liaise with the KEMRI QA group in developing and implementing CDC/KEMRI QA GCP/GLP objectives
Train staff on quality control/assurance issues.
Plan and work towards ensuring DLSP Nairobi laboratory maintains ISO 15139 accreditation status.
Perform other duties as assigned by the laboratory Director, laboratory manager or Principal Investigator.
Requirement Type
At least two (2) years’ relevant work experience
Bachelor of Science degree in any of the following disciplines: Medical Laboratory Science, Medical Microbiology, Biomedical Science, Molecular Biology, Virology, Biochemistry or any other equivalent qualification from a recognized institution.
Registration Certificate issued by the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB) Where applicable
Valid practicing license from Kenya Medical Laboratory Technicians and Technologists Board where applicable;
Proficiency in Computer Application;
Good knowledge of GLP/GCLP Skills & Competencies
Trained in ISO 15189 implementation Skills & Competencies
Fulfil the requirements of Chapter Six of the Constitution. Ethics & Integrity
Fluency in both written and spoken English and Swahili Skills & Competencies
Ability to work and make decisions independently.
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