Labcorp

QA Auditor II

Labcorp Shanghai, Shanghai, China

Medical Practices · 10,001+ employees

7 h ago
qa Junior (0-2 yrs) Full-time China
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About the role

The QA Auditor II is responsible for conducting foundational audit activities, including protocol reviews and facility inspections, while ensuring adherence to regulatory standards and SOPs. They will also provide timely notifications regarding critical issues and suggest improvements for local QA compliance and efficiency.

What they look for

Quality Assurance Auditing Regulatory Compliance GxP Bioanalysis Protocol Review SOP Compliance Critical Thinking Data Assessment Process Inspection Regulatory Knowledge Communication Relationship Management Compliance Improvement

Requirements

Candidates must hold a Bachelor’s degree in Life Sciences and possess at least one year of experience in a regulatory or GxP environment. Preferred qualifications include one or more years of experience in bioanalysis and the ability to interpret operational documents for audit purposes.

Full description

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.

QA Auditor II

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

Job Responsibilities:

  • Follow applicable policies and SOPs
  • Navigate to the regulations and able to read/understand specific regulations
  • Conduct basic foundational audit activities such as, but not limited to protocol review, and internal facility/process and/or supplemental inspections
  • Provide timely notification to management regarding identification of critical issues
  • Build and maintain successful relationships on a one-to-one basis. Answers questions relating to audit findings
  • Participate in liaison meetings and audit finding negotiations
  • Make suggestions for improving compliance and/or efficiency of the local QA organization and business units supported
  • Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed
  • Other duties as assigned by management

Minimum Qualifications:

  • Bachelor’s Degree in Life Sciences.
  • 1 years or more experience in a regulatory environment (experience in GxP roles). 

Preferred Qualifications:

  • 1 years or more Bioanalysis experience
  • Ability to apply basic relevant regulatory knowledge
  • Ability to follow instruction e.g. QA documents (SOPs)
  • Ability to assimilate/interpret operational documents such that audit can be performed to required level

Additional Job Standards:

  • Ability to critically assess data and apply procedures and regulations
  • Adaptability to an ever-changing work environment
  • Ability to recognize gaps in procedures and regulations and consult with more senior QA individuals
  • Demonstrated ability to apply critical thinking skills

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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