QA Compliance Auditor, Central Lab Services at Labcorp in Shanghai China

Job description

• Labcorp is seeking a QA Compliance Auditor to join our team in Shanghai, China.

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

Requirements

• 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
• 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
• NMPA inspection support experiences
• Client audit host experiences
• Vendor audit host experiences
• Familiar with CAP and ISO 15189

Skills

Required

• Knowledge of multiple operational areas

Preferred

• NMPA inspection support experiences
• Client audit host experiences
• Vendor audit host experiences
• Familiar with CAP and ISO 15189