QA Compliance Auditor

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives.

Job Description

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

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.

We encourage all to apply

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