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Job DescriptionQA Compliance AuditorLabcorp 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
Labcorp is proud to be an Equal Opportunity Employer:Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
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