Labeling Engineer

Job Summary

Responsible for managing the labeling process, the full-time remote Labeling Engineer II will plan, conduct, and coordinate labeling activities, ensuring compliance with regulatory requirements and quality standards.

Key responsibilities

• Plans and coordinates detailed phases of the labeling process for projects, ensuring adherence to safety and quality management systems
• Prepares and controls labels and Instructions for Use, tracks labeling documents, and implements Change Control Requests related to labeling updates
• Collaborates with cross-functional teams to execute new labeling for product development and manages labeling translation activities

Required qualifications

• Bachelor's degree in a related field or 3+ years of experience in GMP, FDA, and Change Control processes
• Strong proficiency with Microsoft Office, Adobe InDesign, and Adobe Illustrator
• Knowledge of label creation software and understanding of the regulatory labeling landscape
• Experience in managing labeling documents and ensuring compliance with regulatory standards
• Ability to work collaboratively in a team environment and manage multiple projects effectively