Nairobi Full Time Healthcare
KSh Confidential
2 weeks ago

Job Summary

The regional office of an international AIDS research organization is looking for an experienced laboratory research professional

  • Qualification Level: Bachelor
  • Experience Level: Mid level
  • Experience Length: 3 years

Job Description

The successful candidate will fill the position of LABORATORY QUALITY SPECIALIST.

KEY RESPONSIBILITIES

  • Conduct regular /scheduled laboratory monitoring visits and audits to ensure GCP and GCLP adherence.
  • Perform on-site troubleshooting and technical training including study protocol specific laboratory trainings.
  • Assist in the development of Laboratory QA monitoring and auditing tools.
  • Provide input and support in the development of core laboratory QA processes, including Training, Exceptions-Investigations and Corrective and Preventative Actions.
  • Be part of the Laboratory QA team for review and approval cycle as it pertains to the quality aspect for SOPs, SLMs, Validation documents and other controlled documents.

 

Qualifications

Bachelor degree or equivalent in a biomedical subject /medical technology related field.

Advanced certification in QA, QC or a related discipline

An affiliation with a recognized professional body such as Research Quality Association (MRQA) and or the Institute of Clinical Research ICR.
Proven professional experience in a clinical or research laboratory in the following disciplines:
  • Clinical Chemistry
  • Hematology
  • Microbiology
  • Serology
  • Immunology

Prior experience in Laboratory monitoring/auditing within the research/vaccine/biotech industry.

Working knowledge of GCP/GCLP, Validation, Quality Auditing, and Clinical Protocol Development.

Over three years of experience in a GCLP clinical laboratory or comparable

Experience with writing and reviewing SOPs and analytical/bioanalytical methods for the disciplines detailed above

Familiarity with the principles of document management, change control and Exception Management and CAPAs.

Familiarity with local and national health, safety and environmental regulations.

 

Application site: visit the careers section of our website (www.iavi.org) for details on how to submit application. 

Salary: Commensurate with experience.

https://workforcenow.adp.com/jobs/apply/posting.html?client=intlaids&ccId=19000101_000001&type=MP&lang=en_US#  

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