QA Auditor II-生物分析

该职位来源于猎聘 QA Auditor II Labcorp is seeking a QA Auditor II to join our team in Shanghai,China.

Job Responsibilities: Follow applicable policies and SOPs Navigate to the regulations and able to read/understand specific regulations Conduct basic foundational audit activities such as, but not limited to protocol review, and internal facility/process and/or supplemental inspections Provide timely notification to management regarding identification of critical issues Build and maintain successful relationships on a one-to-one basis. Answers questions relating to audit findings Participate in liaison meetings and audit finding negotiations Make suggestions for improving compliance and/or efficiency of the local QA organization and business units supported Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed Other duties as assigned by management

Minimum Qualifications: Bachelor’s Degree in Life Sciences. 1 years or more experience in a regulatory environment (experience in GxP roles).

Preferred Qualifications: 1 years or more Bioanalysis experience Ability to apply basic relevant regulatory knowledge Ability to follow instruction e.g. QA documents (SOPs) Ability to assimilate/interpret operational documents such that audit can be performed to required level

Additional Job Standards: Ability to critically assess data and apply procedures and regulations Adaptability to an ever-changing work environment Ability to recognize gaps in procedures and regulations and consult with more senior QA individuals Demonstrated ability to apply critical thinking skills