• QC Specialist II

    Job Location(s) CN-Shanghai
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  • Job Overview

    Assists co-workers and internal customers with interpretation of regulatory requirements (e.g., GLPs), SOP requirements, and other guidance documents, as applicable.

    • Reviews data to ensure quality standards are met and to verify compliance to applicable SOP and regulatory requirements.
    • Maintains working knowledge of client SOPs and requirements as applicable. Ensures that data reviewed meets applicable client SOPs and requirements.
    • Performs regularly scheduled audits of departmental systems and supporting data, as applicable, to ensure proper documentation and maintenance (e.g. training files, client SOP reading lists, logbooks, etc.).  
    • Collects error tracking data for items reviewed and reports trends as feedback to the department.
    • Monitors citation trends in eQA and performs follow-up actions with respondents, management, or others, if needed, to prevent recurring citations, problems, or errors.
    • Promotes quality and regulatory compliance within the department by working with operations and scientific staff to resolve service/quality issues, serving on a committee, assisting with the development of training programs related to documentation and quality, or other related involvement.
    • Notifies management of observed quality/compliance issues and service failures.
    • Participates in quality improvement opportunities and harmonization efforts to promote best practices.
    • Participates in project debrief meetings as needed.
    • Facilitates changes to SOPs, policies, training materials, and other documents as applicable.
    • Completes self-development opportunities.
    • Performs other related duties as assigned.




    • Bachelor of Science/Arts (BS/BA) degree.
    • Ability to efficiently use basic software (e.g., Word, Excel, PowerPoint).
    • Experience may be substituted for education. For example, a two-year Associate degree plus 2 years applicable experience may be substituted for a BS/BA degree


    • Two years of laboratory, data review, or related experience with a BS/BA degree.


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