Job Abstract

The Product Labeling Specialist is a multi-faceted position encompassing the development and maintenance of medical device product labeling, informational and instructional literature, packaging, internal document control, change control, process control, and implementation of required regulations and guidelines for multiple Sterility Assurance Products Manufacturing sites. Support all tasks associated with the generation, review and/or updating of documentation, work instructions, labels, Instructions for Use (IFU) and graphics related to the manufacturing, packaging, testing, raw material and finished products, specifications and rework.  

• Change Approver for the PLM Process: Responsible for analyzing submitted ECRs/ECNs related to the labeling process including the evaluation, clarification, and acceptance of an ECR/ECN according to established Quality Systems Procedures. 
• Generate and revise labels, IFUs, and manuals as required utilizing the appropriate software application such as: NiceLabel, Adobe Illustrator, InDesign, Acrobat, Microsoft Word, Excel, etc.
• Fulfill the responsibility as Change Administrator when required to do so as defined by the PLM Corporate Standards and the facilities Quality System Procedures. This pertains to procedures, work instructions and specification sheets, etc.
• Subject Matter Expert (SBM) in graphic design concepts such as layout and digital illustration.
• Participate in software validations as required.
• Responsible for supporting the development and maintenance of medical device product labeling, informational and instructional literature, packaging, internal document control, change control, process control, and implementation of required regulations and guidelines.
• Interfaces with R&D scientists, engineers, engineering designers, graphic design team, regulatory and quality personnel, supervisors, project team leaders, managers, marketing, and operations personnel, vendors, translation project managers, and others to complete new or revised product labeling.
• Handles multiple tasks and projects within overlapping time periods.
• Support product labeling project tasks through creation, development, completion, and release to production via the engineering change process, determining the best combination of resources to complete projects on time.
• Support the development of project supporting documentation as assigned, including scientific documentation, risk management documentation, and on-line matrix databases and documentation.
• Responsible for accuracy and completeness of documentation produced, including proofreading, completing and maintaining design control/project documentation, obtaining necessary approvals, and releasing to operations for production.
• Supports graphic projects from concept through to completion and release to Operations using product lifecycle management.
• Supports the maintenance of the facilities shared network drive for released, revised and archive documentation which are revised outside the PLM environment.
• Interfaces with translation vendor to support the development of universal standards and templates to reduce translation costs, turn-around time while producing quality products, and formats for mark-up languages such as xml and html to facilitate translations. 
• Acquire and maintain a good working knowledge of international language formats and construction, as well as use of regulated graphical symbols, such as ISO/BSI symbols, their proper use and presentation.
• Supports controlled file management structure for a strictly regulated environment for the R&D Graphics department use, and other internal customers as required.
• Coordinates with engineers, designers, scientists, software developers, vendors, STERIS IT, and outside resources to resolve project design and software application issues.
   

• 2 years technical writing/graphic design/product labeling with a bachelor's degree OR 5 years technical writing/graphic design/product labeling without a bachelor's degree.
• Minimum five years of experience with electronic desktop publishing equipment and layout programs, Adobe Creative Suite preferred.
• 2+ years of product labeling experience such as color specifications, logo, branding, trademark usage, UDI, GHS, regulatory, market requirements, shipping regulations.
• 2+ years of experience with graphic design and product labeling coordination such as IFUs, package inserts, package/machine labels, cases, cartons, user manual and guides (wall charts, pamphlets).
• 2+ years of experience working with outside print vendors.
• Coordinate with production on materials management, MRP (stocking, usage, inventory, purchasing).
• Demonstrated ability and interest in leading, mentoring, training and guiding others. 
• Strong communications experience and demonstrated ability to build positive rapport and partner with Operation, support groups and Vendors. 
• General knowledge of personal computers.
• Standard knowledge of equipment operation and maintenance across entire product portfolio, demonstrated ability to troubleshoot. 
• Ability to work flexible hours, sometimes outside “normal business hours” and travel as required.
• Must be experienced with Design/graphics software, Adobe Creative Cloud, Product Change Management Systems, Oracle (or other ERP system), and MS Office.

#LI-BN1