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Laboratory Quality Assurance Officer



2 months ago

Job Description

KEMRI-Wellcome Trust Research Programme is seeking to hire a Laboratory Quality Assurance Officer. The role is to develop, monitor and implement comprehensive quality assurance programmes and processes that will ensure the maintenance of laboratory Quality Management Systems (QMS) to internationally recognised Good Clinical Laboratory Practice (GCLP) standards.

Required Knowledge, Skills, and Abilities

  1. Develop, monitor and implement quality assurance compliance objectives and programs and report on progress/ level of compliance
  2. Participate in the development, review, update and implementation of quality policies, procedures and monitoring tools
  3. Liaise with managers and operating staff within the laboratories to ensure that QA/QC procedures are continuously monitored with well documented corrective action where appropriate
  4. Collate and analyse performance data and charts against defined parameters
  5. Organise internal audits as per identified auditable areas, train internal auditors, co-ordinate internal audits and ensure document all audit findings are documented
  6. Liaise with the external auditors, monitors and inspectors in conducting audit activities including scheduling audits, facilitating audits and working with relevant staff to implement actionable areas/findings
  7. Maintain laboratory staff training database, identify and coordinate quality related training needs, develop training programs and materials and conduct training
  8. Promote quality achievements and performance improvement within and throughout the laboratories
  9. Coordinate regular QMS performance meetings with designated personnel from each laboratory discipline to communicate objectives, discuss performance and identify areas of improvement
  10. Ensure maintenance and control of laboratory QMS records and documentation
  11. Prepare and submit reports as and when required
  12. Prepare research papers for presentation at conferences or publication
  13. Deputise and fill-in for other quality staff as may be required
  14. Any other duties that may be assigned from time to time

Education + Experience

  1. QUALIFICATIONS: Degree in medical laboratory technology, biomedical sciences, laboratory management or equivalent
  2. At least 3 years experience in a research or medical laboratory/ medical lab QA role
  3. Professional qualification in laboratory quality assurance
  4. Training in laboratory quality management systems, quality assurance programs or equivalent
  5. Sound knowledge and understanding of lab QMS’s, GCLPs and ISO 15189 standards
  6. Computer literacy with proficiency in Microsoft applications