Performs protocol, data, report, and in-lab phase inspections for specific study types 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).
Performs SOP reviews as appropriate
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/review (internal/external) and report finalization.
Participates in internal facility and supplemental inspections.
Capable of delivering basic quality/regulatory training.
Actively participates in 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 years of experience as a quality auditor in a GxP-regulated environment or at least three years working experience in GxP regulated environment.
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