QA Compliance Senior Auditor, GCP -Central Lab Services

Role Summary

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.

Senior QA Compliance Auditor

Labcorp is seeking a Senior QA Compliance Auditorto join our team in Shanghai, China.

Responsibilities

• Hosts and support regulatory inspections, e.g. NMPA
• Hosts and coordinate lab accreditation inpsections, including CAP, ISO 15189
• Hosts sponsor audits
• Coordinates client request for information questionnaires
• Conducts internal audits per global audit plan
• Conducts vendor and supplier audits per global audit plan
• 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.
• 6 years or more experience as Central Lab QA/BioA QA .
• 6 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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About the Company

Why People choose to work at Labcorp

At Labcorp, it is our people that make us great - it is what our clients, our partners and, most importantly, what our employees say. Here, you will have the opportunity to collaborate with extraordinary people with diverse viewpoints. You will discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends.

#LifeAtLabcorp

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