Covance QC Specialist II in Shanghai, China

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.

Education/Qualifications

  • 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

Experience

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

Job Number 2018-20506

Job Category Other

Position Type Full-Time

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