Nairobi Laboratory Specialist

JOB TITLE: Laboratory Specialist

REPORTS TO: Senior Laboratory Specialist, African Regional Office (AFRO)

JOB SUMMARY:

Perform laboratory audit and provide technical assistance, capacity building, training, and quality assurance services to clinical laboratories serving, FHI 360 research, public health programs and Clinical Research Services Support (CRSS). In addition, provides these same services to third-party funded programs. Prepares laboratory procedures and manuals and trains staff in their use. Prepares reports and leads the follow-up of technical assistance and assessment visits to include corrective actions and capacity building initiatives.

DUTIES AND KEY RESPONSIBILITIES:

Working closely with Laboratory Specialists (AFRO, and APRO research and public health program staff provide technical assistance, quality/GCLP assessment and capacity building services to ensure and enhance the quality of laboratory services associated with FHI program and research areas. Specifically, the key responsibilities are:

1. Conduct laboratory/clinic audits incompliance with applicable guidelines such as DAIDS GCLP guidelines.
2. Provide adequate review for audit reports conducted by fellow specialist.
3. Planning, conducting, and reporting of laboratory assessment, audits and accreditation – ready inspections of clinical laboratories performing services to FHI 360 and similar support required by sponsors.
4. In close collaboration with laboratory management lead the follow-up of needed corrective and preventive actions.
5. Responsible for initiating continuous improvement initiatives upon request to build laboratory capacity and quality with reference to accepted standards and requirements.
6. Assist in incorporating lab strengthening and clinical laboratory functions and services into programs.
7. Assist with the preparation and delivery of laboratory trainings and training-related services.
8. Perform other duties as assigned.

CONTRIBUTION:

1. Assist with delivery of laboratory quality audits incompliance with applicable guidelines such as DAIDS GCLP guidelines.
2. Assist with the preparation and delivery of trainings to laboratory staff to include general laboratory technician training and laboratory supervisor training.
3. Assist laboratories with developing quality systems to include an overall Quality Management Plan, routine SOP development, quality control and quality assurance systems, staff training, and others as needed.
4. Encourage and assist laboratories with preparing for and seeking accreditation through locally, regionally, nationally, and internationally accepted accreditation agencies.
5. In close collaboration with laboratory management develop and assist with the implementation of corrective actions and implementation of continuous improvement systems, procedures, and measures.
6. Assist laboratories with setting up internal quality control systems and/or participating in External Quality Assessment Schemes.
7. Perform other duties as assigned.

KNOWLEDGE, SKILL, ABILITIES, EXPERTISE AND COMPLEXITY:

1. Working knowledge of quality laboratory audit.
2. Proven capability and direct experience in clinical and research laboratory functions and services, including in resource constrained settings.
3. Resourceful and creative thinker with the ability to develop simple and efficient solutions and recommendations.
4. Excellent attention to detail.
5. Experience in Laboratory audits.
6. Excellent interpersonal skills, particularly diplomacy.
7. Good in both written and spoken English and report writing. Working knowledge of French an asset, but not required.
8. Direct experience developing and delivering trainings in laboratory sciences.

MINIMUM REQUIREMENTS:

Degree in Biological Science or Laboratory Sciences within a clinical or diagnostic discipline with 5-7 years relevant experience or Higher National Diploma in Medical Laboratory Technology with 7-9 years relevant experience within a clinical or research laboratory including experience with laboratory audit, quality control and quality assurance systems and implementation. Supervisory experience is preferred. Ability and aptitude to provide detailed laboratory audit and capacity building services and to perform quality assurance assessments against accepted national and international standards and GCLP requirements. Demonstrated creative problem solving skills. Demonstrated excellent written and oral communication skills including experience in training and mentoring staff and audit. Ability to travel within Kenya and across Africa for up to 50% of the time.

Nairobi

Laboratory Specialist