As a Labeling Specialist, you will be responsible for the research, overall development and execution of the new Global Labeling Projects for client businesses. In addition, will be responsible for the development and maintenance of a labeling database including label artwork trace-ability. You will ensure compliance to internal requirements, systems and external standards and regulations to implement labeling projects on schedule.
The Labeling Specialist 2 is responsible for labeling applied to all forms of packaging, Instructions for Use (IFU’ s), all artwork approvals thru the change management system and working with vendors for language translations. This person will be responsible for understanding and implementing FDA, internal and international regulations and standards related to product labeling.
This position does not include creation or preparation of Marketing promotional materials.
· Research, review, gather, and correlate existing labeling. Document findings in Excel and report.
· Evaluate to ensure compliance to relevant regulations and standards are met.
· Organize, compile, and maintain all labeling and artwork and ensure version control.
· Create, update and maintain labeling, graphics, and specifications for new and existing labels that are compliant with procedures, FDA and International regulations, and manufacturing of labeling in production.
· Participate in the development of new and updating existing product labeling (Product labels and IFUs) for both domestically and internationally.
· Communicate with other team members of labeling changes for faster and easier approval.
· Development and maintenance of labeling database including artwork revision trace-ability.
· Organize and maintain the approved artwork file database.
· Creation of change requests utilizing the electronic documentation system.
· Develop labeling strategies as needed.
· Participate in process improvement projects and propose solutions.