Label Control - Specialist

GENERAL PURPOSE

To review and source printed packaging in support of ongoing and concurrent packaging efforts, including the label (printed components) stock controls, finish label (printed components) security, regulatory document controls/maintenance and quality/proof reading of printed packaging components.

Liaise with the Account Management, Sales, R&D and printed component suppliers by coordinating the label proofing and sourcing activities of designated projects to ensure that the goals or objectives of that project are accomplished within the prescribed time frame. 

Works under the guidance of the Label Control Supervisor and/or Senior Label and Printing Manager.

 Manages requests for labeling information, from various source or reference documents.

 Notifies appropriate groups regarding changes or recent source/reference labeling approvals.

 Prepares country-specific labeling text in support of safe and appropriate use of products for in-scope countries; maintains country specific translation master-copy to meet labeling responsibilities.

 Prepares, tracks, maintains and reviews required labeling documents (e.g., label, insert, carton, label, blister) using process tools to maintain change history for all labeling documents.

 Ensures all labeling supporting documentation and final approved labeling documents (approved content and final artwork) match, are status updated, and tracked in the electronic data management system or systems.

 Initiates and approves final printed artwork, when needed for artwork changes and assists with timely implementation of the updated artwork in the market.

 Notifies the artwork team, manufacturing, global planning, and supply representatives as needed of upcoming changes to labeling. Provide guidance as to when the changes need to be implemented based on information supplied by each market affected.

 Maintains an understanding of regulatory labeling requirements of assigned products and countries.

 Assist in the documentation and written support of investigations, deviations and CAPAs should they arise.

 Manage multiple concurrent label room activities for projects at different stages of the production cycle, to best meet timelines and keep packaging for production moving.

 Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that result in a product recall due to labeling.

 Maintains an understanding of regulatory labeling requirements of assigned products.

 Monitor and maintain label stock inventories.

MINIMUM QUALIFICATIONS 

Education: High School Diploma required.

Experience: Minimum 1 Year Experience in a cGMP Environment. 1-2 years of experience in Quality Assurance or production, preferably in the nutraceutical, pharmaceutical or cosmetic industry.

Knowledge, Skills, and Abilities:

 Must be able to read and understand English job instructions and safety requirements.

 Attention to detail, critical thinking, and computer skills required

 Ability to use word processing, Excel, Word, ERP and WMS systems.

 Basic understanding of CFR Part 111, and CFR Part 211 and GMP

Certification or License: None