職位描述
Responsibilities / Duties:
Performs protocol, data, report, and in-lab phase inspections for a specific study type 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).
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 (internal/external) and report finalization.
Performs SOP reviews for specific study type.
Starts to participate in internal facility and supplemental inspections, under supervision.
Starts to deliver basic quality/regulatory training, under supervision.
Identifies opportunities for process improvement and harmonization efforts that promote best practices.
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
企業簡介
科文斯，全球性的合同研究組織（CRO）Covance Inc.是全球服務最全面的藥物研發公司。
我們致力于推動醫療保健事業發展并實現Solutions Made Real?，通過向制藥公司和生物科技公司提供高質量的非臨床、臨床前試驗、臨床和商業化服務，幫助減少藥物研發的時間和成本。憑借豐富的經驗與深厚知識，我們具備獨特的優勢，能為客戶合作伙伴提供不僅僅局限于測試的獨到見解。
我們還向化學品、農用化學品和食品行業提供實驗室測試服務，同時也是毒理學分析服務、中心實驗室服務、藥物篩選服務的市場領導者，以及III期臨床試驗管理服務的全球頂級提供商。
科文斯官網： https://www.covance.com/
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