The successful candidate will fill the position of LABORATORY QUALITY SPECIALIST.
regular /scheduled laboratory monitoring visits and audits to ensure GCP and
on-site troubleshooting and technical training including study protocol
specific laboratory trainings.
in the development of Laboratory QA monitoring and auditing tools.
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
Bachelor degree or equivalent in a biomedical subject /medical technology related field.
Advanced certification in QA, QC or a related discipline
- Clinical Chemistry
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.