• GLP QA Officer II

    Job Location(s) CN-Shanghai
    Job Number
    Job Category
    Quality Assurance
    Position Type
  • Job Overview

    • 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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