Senior Packaging Graphics Specialist--Temporary--12 Months (Remote)

JOB SUMMARY - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Manages labeling and graphics direction and support in the design, development and procurement of medical device labeling. Medical Device labeling includes, but is not limited to, product labeling, pre-printed pouches, pre-printed boxes, Directions for Use, Patient Guides and Patient Cards. Key team member to ensure that labeling meets all medical, legal, and regulatory requirements. Oversees status of label copy and availability concerning packagers, translators, or publishers. Project lead for various projects and responsible for coordinating resources to ensure successful project completion. This position requires very detail oriented work involving data entry, graphic design work, label printing and various administrative duties and the ability to handle multiple projects and priorities.

Essential Duties and Responsibilities

• Responsible for all Product labeling including design, control, issue, revise, create, format, obsolete, print, and approval. Labeling includes product labels, box labels

• Graphics creation for use in multiple systems

• Label Design

• OQ testing of label formats prior to release

• Package Artwork Design

• Data Entry

• Label printing, checking and approving

• Checking graphics

• Scanning and Copying

• Creating labeling and graphic redlines- electronic and manual

• Creating Bill of Material notes redlines in regards to labeling

• Coordinating Approval Process

• Coordinate Label Translations and set-up with translation vendors and publishers

• Track progress of Graphics Projects

• Barcode verifications

• Coordinate labeling and labeling requirements with outside distribution projects

• Troubleshoot issues

• Uses the Agile PLM Change Control System -to coordinate and obtain approval of labeling

• Participates as core team member on product and process projects as they relate to graphics and labeling. Provides input on capability and impact of proposed labeling along with timelines.

• Responsible for creating/maintaining Work Instructions that define labeling/graphic processes

• May perform other duties as assigned

QUALIFICATIONS -The requirements listed below are representative of the knowledge, skill or ability required.

Education and Experience

• Bachelor's Level of Degree in the General field of study preferred

• 3-5 years of demonstrated experience in Graphic Design

• Acrobat Writer Skills preferred

Skills/Knowledge

• Extensive knowledge of medical device product labeling

• Ability to balance multiple project and priorities

• Proven accuracy skills are mandatory

• Sense of urgency a must

• Experience working in a detail-critical setting with multiple priority changes a plus

• Ability to work in a team environment required

• Proficient in the following computer software applications: Microsoft Office/Adobe software, In-Design software, Illustrator and database management software

• Exceptional interpersonal skills.

• Strong organizational skills.

• Strong communication skills (written and verbal).

• Ability to effectively communicate both internally and externally.

• Ability to read and interpret documents such as safety rules, operating and maintenance. instructions, and procedure manuals. Ability to write routine reports and correspondence.

• This position requires some travel up to 10% of the time