QA Auditor V

Job Number
Job Category
Quality Assurance
Position Type

Job Overview

Performs protocol, data, report, and in-lab phase inspections for a specific study type to verify conformance to applicable SOP and regulatory requirements.

  • Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.
  • Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records).
  • Notifies management of service failures.
  • Manages all aspects of personal, daily micro-scheduling, organization and prioritization related to a full workload.
  • Performs study sign-off including but not limited to QA statement preparation (internal/external) and report finalization.
  • Performs SOP reviews for specific study type.
  • Starts to participate in internal facility and supplemental inspections, under supervision.
  • Starts to deliver basic quality/regulatory training, under supervision.
  • Identifies opportunities for process improvement and harmonization efforts that promote best practices.
  • Performs other related duties as assigned.


  • Bachelor of Science/Arts (BS/BA) degree; degree in a science field is preferred (e.g. chemistry, biology, animal science)


  • At least 2 year of experience as a quality auditor in a GxP-regulated environment or similar working experience in a GxP-regulated environment.


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