Covance

QA Auditor V

CN-31-Shanghai
Job Number
2018-16707
Job Category
Quality Assurance
Position Type
Full-Time

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.

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

Education/Qualifications

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

Experience

  • 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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