QA Auditor IV-Bioanalysis

QA Auditor IV

Labcorp is seeking a QA Auditor IVto 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:

• Experienced in process improvement
• Demonstrated ability to apply critical thinking skills
• 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