QA Compliance Auditor-Central Lab Services

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

Job Responsibilities: Support and assist regulatory inspections, e.g. NMPA Support and assist lab accreditation inspections, including CAP, ISO 15189 Support and assist sponsor audits Coordinates client request for information questionnaires Conducts internal audits per global audit plan, as local auditor Conducts vendor and supplier audits per global audit plan, as local auditor Contributes to global QA policies and SOP review and drafting Provide subject matter expertise to projects internal and external customers’ questions on regulation interpretation Delivery of training to new QA members if needed Participate global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization

Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements

Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed

Other duties as assigned by management

Minimum Qualifications

• Bachelor Degree in Life Science.
• 4 years or more experience as Central Lab QA/BioA QA .
• 4 years or more experience in GCP/GLP regulatory environment Preferred Qualifications: NMPA inspection support experiences Client audit host experiences Vendor audit host experiences

Familiar with CAP and ISO 15189

Additional Job Standards

• Knowledge of multiple operational areas
• Clear communication skills, including ability to provide clear feedback
• Able to clearly articulate processes to provide training
• Able to influence process improvement initiatives and offer solutions