IMMEDIATE NEED for Regulatory Affairs Specialist - Graphic Design candidate to join Regulatory Affairs department with multinational pharmaceutical client in Rochester, NY!Client is actively interviewing and looking to bring someone on very quickly!Description:Objective: Leader for labeling/packaging graphic projects, including development of packaging production artwork and handling of project management tasks.Responsibilities:Independently manage a steady stream of projects. This includes preparation and development of approved, print-ready packaging production artwork, as well as project management activities to ensure efficient completion.
Manage artwork approval process, including interaction with Regulatory, Marketing, Legal, Engineering, Quality and Supply Chain.
Closely follow defined processes and documentation to ensure highest quality and compliance to cGMP and FDA requirements.
Provide graphics/process support and advise to internal plants, external manufacturers and print suppliers.
Maintain artwork files, electronic files and artwork archives. Ensuring established standards for file build and metadata tagging are met.
Participate and contribute to continuous improvement projects. Proactively identify areas of improvement.
Additional Skills & Qualifications:BA in Graphic Design, BS in Packaging (Design), BS in New Media or Printing or equivalent experience.
Must have in-depth, working knowledge of Adobe Illustrator and InDesign.
Print knowledge and experience required.
Understanding of GMP requirements working in a regulated environment a plus.
Minimum 3-5 years labeling development experience with extensive mechanical file preparation or production art experience required.
Additional Benefits:Quick Access to Benefits: Medical, Vision, Dental, 401(k)
PTO, Holiday Pay Offerings!
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