R&D Audit - Senior Associate - Remote

Overview

In this vital role, you will support the R&D quality audit and help to build quality into everything Amgen does, ensuring compliance and excellence in operations.

In Short

• Support R&D quality Audit processes
• Data entry into Amgen’s Quality System
• Quarterly Investigator Site audit planning
• Compile Audit reporting metrics
• Manage Audit documentation and filing
• Support outsourced audits and manage resources
• Oversee timelines for audit reports
• Communicate noncompliance issues
• Provide administrative support for audits
• Follow up with CAPA Owners for completion

Requirements

• Master’s degree in Life sciences or related field
• 3-5 years in biopharmaceutical industry experience
• Experience in Quality Management and Assurance
• Knowledge of Quality Management Systems
• Experience with electronic QMS like Veeva or Trackwise
• Quality Assurance Qualification/Certification preferred
• Experience with regulatory authority inspections
• Strong communication skills
• Ability to manage multiple tasks efficiently
• Problem-solving skills

Benefits

• Work with innovative professionals
• Opportunity to impact patient health outcomes
• Engage in meaningful work
• Access to advanced tools and technologies
• Professional development opportunities
• Collaborative work environment
• Competitive compensation package
• Comprehensive health benefits
• Flexible work arrangements
• Commitment to diversity and inclusion