The Labeling Assurance Specialist will design, typeset, proofread, and coordinate the development of labeling materials, specifically for patient guides, physician manuals, additional labels, and instructions for use. This position will interact with other departments to assure labeling is in compliance with regulations and company policies.
- Collection of labeling content requirements from design team.
- Design of labeling materials (instruction for use, patient guides, additional labels) in the graphic design software to produce labeling materials that conform to pre-determined sizes and standards.
- Proof of various documents against source files to ensure accuracy.
- Management of multiple files through the process of review, approval, translation, and printing while maintaining strict version control.
- Collaboration with Labeling Assurance team members in order to provide status of labeling-related project deliverables.
- Update Labeling Assurance team members and design team to ensure labeling-related project deadlines are met.
- Review of upcoming labeling design changes to anticipate project load.
- Compile version history of instruction for use for legal, audit support, and internal request.
- Advise design team of internal Instruction for Use requirements.
- Communicate with outside vendors to answer questions and ensure adherence to project schedules.
- Bachelor’s degree or High school Diploma/GED with min. 2 years experience years relevant experience in a graphic arts environment
- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink
- Familiarity / knowledge of Adobe graphic design software (InDesign, Photoshop, Illustrator)
- Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit, stand, walk, and communicate.
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to supply sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position.