The Labeling Assurance Specialists facilitates and coordinates the handling of labeling materials, including product labels, Instructions for Use (IFUs), and patient guides, through the graphic design, approval, and archiving processes.
- Assist in the graphic design of product labels (in the Prisym labeling software) and labeling materials (in appropriate Adobe graphic design software).
- Draft label specifications for product labels.
- Proof labeling material documents against source files to ensure files meet established specifications.
- Management of multiple files through the process of review, approval, translation, and printing while maintaining strict version control.
- Collaborate with Labeling Assurance team members in order to provide status of labeling-related project deliverables.
- Communicate with Labeling Assurance team members and design team to ensure labeling-related project deadlines are met.
- Prepare IFUs for electronic display on Cook website.
- Electronically archive previous revisions of IFUs.
- Assist in the routing of product labels and labeling materials for review and approval (in the PLM system).
- Print sample labels for internal / external requests.
- Provide version history of IFUs for legal, audit support, and internal request.
- Assemble list of products associated with specific IFUs for internal request.
- Compile label content information for internal / external requests.
- Maintain inventory of label stocks and printer ribbons for the Labeling Assurance department.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- Employee Code:
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
- Ability to remain calm and receptive in fast paced situations.
- Bachelors degree; or experience of such kind and amount as to provide a comparable background.
- Graphic design experience in a regulatory controlled industry, preferred.
- Proficient in Microsoft Word/Excel/Outlook/LiveLink/PLM/Global Product File (GPF), and JBase, preferred but not required.
- Familiarity / knowledge of Adobe graphic design software (InDesign, Photoshop, Illustrator) is preferred.
- General familiarity with labeling software (Prisym or other) is preferred.
- General familiarity / knowledge of the different systems used by Cook Inc. to store information (LiveLink, PLM, Global Product File (GPF), jBase) is preferred.
- Must be self-motivated individual with the ability to work as part of a cohesive team.
- Must be willing to quickly learn and comprehend new skills.
- Ability to, while managing time and priorities effectively, achieve thoroughness and accuracy when accomplishing tasks is a must.
- Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit, stand, walk, and communicate.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**