职位描述
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
企业简介
科文斯，全球性的合同研究组织（CRO）Covance Inc.是全球服务最全面的药物研发公司。
我们致力于推动医疗保健事业发展并实现Solutions Made Real®，通过向制药公司和生物科技公司提供高质量的非临床、临床前试验、临床和商业化服务，帮助减少药物研发的时间和成本。凭借丰富的经验与深厚知识，我们具备独特的优势，能为客户合作伙伴提供不仅仅局限于测试的独到见解。
我们还向化学品、农用化学品和食品行业提供实验室测试服务，同时也是毒理学分析服务、中心实验室服务、药物筛选服务的市场领导者，以及III期临床试验管理服务的全球顶级提供商。
科文斯官网： https://www.covance.com/
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