Quality Assurance Auditor

About the role

The Quality Assurance Auditor supports supplier qualification, approval, and ongoing oversight for manufacturing facilities, ensuring compliance with industry regulations and McKesson quality standards.

Responsibilities

• Conducts on-site audits of domestic and international suppliers to evaluate quality systems, manufacturing controls, and regulatory compliance (FDA, cGMP, ISO)
• Prepares detailed audit reports, identifies risks, and collaborates with stakeholders to monitor corrective actions
• Supports supplier qualification programs and maintains knowledge of applicable regulations
• Builds professional relationships with suppliers and partners through extensive travel

Qualifications

Requires 4+ years of experience in quality audits within regulated environments, a bachelor's degree in Science or related field, and strong knowledge of FDA regulations, cGMP, and ISO standards.

Skills

• Demonstrates excellent communication, project management, and organizational skills, with the ability to travel extensively
• ISO 13485 Lead Auditor certification is preferred
• Additional certifications like ASQ CQA or bilingual skills are advantageous