上海招聘

  

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                          

• At least 1 year of experience as a quality auditor in a GxP-regulated environment or at least two years working experience in GxP regulated environment.

  

LabCorp是全球顶尖的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。

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