Leader for labeling/packaging graphic projects, including development of packaging production artwork and handling of artwork project tasks..
Independently manage site produced US labeling, and the development of International labeling processes (trademark/copyright) for assigned global regions and a steady stream of projects.
Manage artwork approval process, including interaction with Regulatory, Marketing, Legal, Engineering and Quality.
Closely follow defined processes and documentation to ensure highest quality and compliance to cGMP and FDA requirements.
Confirm reqirements stated on the Artwork Checklist are met for updated artwork.
Work independently to review artwork for overall compliance to established artwork standards. This includes reviewing redline changes, specifications, barcode requirements, colors (spot/process), file maintenance/bleed, separations, fonts, images, branding guidelines, translations, lot/exp format, trademark/copyright, create vendor files for printer.
Maintain artwork files, electronic files and artwork archives. Ensuring established standards for file build and metadata tagging are met.
Manage Vendor/Printer artwork approval process including creating vendor files, uploading comparable, proofing and approving artwork. Receiving & distributing samples and LSDs (Light, standard, darks) consistent with established standards for Contract Manufacturing and International Labeling.
Global coordination of packaging graphics including standardization of designs (Global Branding) for worldwide use.
Support and interaction for all projects impacting art, labeling and packaging.
Understanding of GMP requirements working in a regulated environment.
Responsible for US Labeling document control process to transfer US artwork into Tampa's quality system. Downloading approved US artwork from ELM and following Quality process to make artwork effective in D2.
Write, submit and manage approval of change requests in Global Document Management System (Documentum). Compliance with cGMP, FDA Regulations, and an understanding of regulated documents and change control.
Participate and contribute to continuous improvement projects. Proactively identify areas of improvement. Perform testing on projects with appropriate feedback. Create test and stability labeling for Packaging Engineers.
Assists in preparation of responses to labeling-related Health Authority queries. Ensures deviations from labeling procedures and policies are escalated appropriately. Provides input and strategic guidance to the specified Country's point of contact and Regulatory Authority. Planning, production and applications for assigning & tracking part #s, UPC, RSS, GTIN etc. including the use of Sharepoint, Excel, Agamik Barcoder, Illustrator, InDesign, Adobe Acrobat Pro, Mircosoft, Elm, Kintana, D2.
Minimum 3 years graphic/labeling development experience with extensive mechanical file preparation or production art background required.
Must be solid in Photoshop, Illustrator, InDesign and the full Creative Suite. Should be skilled with mechanicals, versioning, comps and resizing. Print knowledge and experience required. Familiarity with Marketing collateral or CPG preferred.
Experience in PDF-based file development and workflow for multiple end uses, including print.
Experience with internet applications along with knowledge of digital asset management and XML a plus. Experience with pharmaceutical, medical device or consumer packaging is necessary.
Understanding of Pharmaceutical and Medical Device regulations including documentation and reporting requirements.
Experience with NDA and ANDA submissions a plus.
Experience with Plant support as it relates to documentation and spec changes that are affected by labeling, art and print changes.
Expertise in Adobe Creative Suite (Illustrator, Photoshop, InDesign, Acrobat), and Microsoft Office.
Ability to troubleshoot issues with both software and hardware. Familiarity with Barcode Symbology (i.e. UPC, Code-128, Data Matrix, etc.) for both MAC/PC applications. Web design or flash experience a plus.
Must be self-starter and have ability to work independently. Proven ability to manage multiple projects/activities. Must be able to handle quick turnarounds, while maintaining high quality in a fast paced environment.
Bausch & Lomb