QA Auditor IV

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 IV

Labcorp is seeking a QA Auditor IV to join our team in Singapore. Job Responsibilities:

• Conduct, but not limited to protocol, data/report review, where applicable for specific study types
• Lead internal facility/process inspections
• Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
• Report on relevant quality metrics and highlight trends
• Provide consultation to the operational team
• Delivery of training in performance of audits
• Work with operational management to support Quality topics and/or working on projects with QA team on other sites
• Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization
• Create and/or re-write QA SOPs based on findings from local quality initiatives
• Organizing, Prioritizing and Managing all aspects of workload to meet business needs
• 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 preferred (or equivalent Life Science experience)
• 3 years in a regulatory environment (Experienced GxP auditor)
• Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance

Preferred Qualifications:

• At least 2 or more years of QA experience
• Experience may be substituted for education
• 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: