Labeling Specialist
On-site · Palm Harbor, Florida, United States
Job Summary
The Labeling Specialist is responsible for preparing, creating, and controlling labels and Instructions for Use throughout the product lifecycle, ensuring compliance with FDA regulations and internal quality standards. Key responsibilities include tracking labeling documents, preparing labeling translations, conducting vendor proof reviews, maintaining the FDA UDI GUDID database, and collaborating with cross-functional teams to support labeling projects for new product development. Candidates should possess a minimum of three years of experience related to GMP and FDA regulations, a strong understanding of labeling requirements, and proficiency in Adobe InDesign and Illustrator.
Required Qualifications
- Minimum of three years of experience of GMP, FDA, Change Control process
- General understanding of U.S. FDA UDI and EU MDR labeling requirements
- Experienced with Microsoft Office
Desired Qualifications
- Strong attention to detail
- Strong organizational and time management abilities
- Strong proficiency with Adobe InDesign
- Proficiency with Adobe Illustrator
- Knowledge of label creation software
Additional Requirements
- U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
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