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 1 year of experience as a quality auditor in a GxP-regulated environment or at least two years working experience in GxP regulated environment.
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