Duration
- 1-2 day audit + additional time for drafting audit findings report
Job Description
- Our client is seeking an auditor to assist with an upcoming qualification audit for biomarker analysis. This resource will have to have a firm understanding of techniques for biomarkers such as genetic biomarkers in human specimens. Furthermore, understanding within the appropriate guidelines regarding bioanalytical, GCP, CLIA and other guidelines for method development, method validation human samples for clinical as well as the related analytical techniques for related studies.
- Once the auditor is selected, the auditing process will consist of being introduced to the QA person at the site, review/draft the audit agenda, conduct audit, debrief with POC, draft final audit report attesting to topics that are uncompliant/compliant, reference data that was reviewed to support the conclusions and send audit report for review. If candidates have their own auditing templates that are successful that they can utilize, this will be deemed very helpful.
Remote: Biomarker Analysis Auditor (235085)
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