fhi360 Laboratory Specialist in Bangkok, Thailand
Plans, conducts and reports assessments, audits, and accreditation-ready inspections of clinical laboratories performing services to FHI 360 research and programs. Prepares reports and leads the follow-up of those visits to include corrective actions and capacity building initiatives. Further assist with laboratory capacity building initiatives within the APRO and African region through preparing and delivering trainings. Co-ordinate and facilitate the clinical laboratory quality improvement program including preparing laboratories for ISO 15189 and GCLP accreditation. Prepare and deliver laboratory trainings and training-related services to FHI 360 research program and to external agencies. Provide technical assistance to diagnostic laboratories in Asia and Africa.
DUTIES AND KEY RESPONSIBILITIES :
Working closely with the Laboratory Sciences global team, APRO study specific research staff and APRO service delivery staff and others, conduct laboratory assessment and capacity building initiatives to ensure and enhance the quality of laboratory services. The key responsibilities are:
Responsible for the planning, conduct, and reporting of assessments, audits, and accreditation-ready inspections of clinical laboratories against ISO 15189 and GCLP performing services to FHI360 research and programs.
In close collaboration with laboratory management lead the follow-up of needed corrective and preventive actions following audits.
Responsible for developing and implementing continuous improvement initiatives upon request to build laboratory capacity and quality with reference to ISO 15189 and GCLP standards and requirements.
Take active role in developing generic Quality Manual, SOPs, and work instructions with reference to ISO 15189, GCLP and other standards.
Provide technical assistance to laboratories and others as needed and requested as part of overall capacity building and continuous improvement schemes.
Preparation of training materials and deliver trainings to research program, laboratory staff and external agencies.
Provide technical assistance to set up (laboratory set up plan review) and quality operation (develop and review SOPs, develop instrument and supplies list and develop and review carry over contamination prevention plan) of diagnostic laboratories in Asia and Africa.
Perform other duties as assigned.
WORKING CONDITIONS AND PHYSICAL REQUIREMENTS:
Usual office working conditions when in the APRO office base location. Ability to travel within Thailand and the Asia Pacific or Africa regions for up to 50% of the time.
Masters degree in biological or laboratory sciences within a clinical or diagnostic discipline or specialty.
At least two years related work experience in laboratory quality assurance, quality control and audits.
Demonstrated ability and aptitude to perform quality assurance laboratory audits and assessments against accepted national and international standards and regulations.
Demonstrated creative problem solving skills.
Demonstrated excellent written and oral communication skills including experience in training and mentoring staff and others.
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.
As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.