Product Labeling And Documentation Specialist Ii
Current• Create, update, and review literature, labels and other printed materials for regulated diagnostic products.• Perform all work in compliance with company policies, within the company Quality System and Regulatory guidelines, and with minimal direction from management.• Create and present mockups, sample labels, and other documents to stakeholders from various groups.• Assist in and write verifications and validations of labeling material, labeling software, and printers.• Create, update, and review drawings for pre-printed labels, pouches, bags, and other materials, working with vendors/suppliers as needed.• Work with manufacturing, regulatory, quality control, program management, marketing, engineering, research and development, materials management, and legal groups coordinating timely incorporation of labeling and literature changes.• Ensure labels and documents are released into the company Quality System according to established processes. • Create and revise labeling work instruction documents when needed.• Troubleshoot labeling issues and assist with labeling-related CAPAs.
