Labeling Assurance Specialist

Posting Date 7 months ago(3/8/2022 4:08 PM)
Requisition ID
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Cook Inc - Bloomington
Product/Project Management


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
minimal supervision.
- 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.


Physical Requirements:

- 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.**



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