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Labeling Specialist
Ref No.: 18-06487
Location: Sinking Spring, Pennsylvania
Position Type:Full Time/Contract
Start Date / End Date: 10/01/2018 to 10/01/2019
Coordinate product labelling implementation from change control initiation to manufacturing implementation. Tasks will include:
Initiation of change control and management of sub-tasks related to the change control process.
Coordinating with design facilities and providing approved artwork to vendors as necessary for the label development and printing processes.
Development of APD label specifications, assignment of label item numbers, and assignment of specification and artwork control numbers
Processing of all controlled document changes necessary for label implementation under approved document change processes. Ensuring the accuracy of data entry related to any document changes.
Manage timeline of label implementation with Global EU MDR transition group and coordinate with buyer/planners and manufacturing personnel to ensure a smooth transition when new product labeling is introduced.
Collaborate with engineers to develop or revise bills of materials and associated device master record indexes, as necessary for label implementation.
Administration of the item master files (parts list) in the MRP system as it relates to label changes.

Strong Project Management skills
1-2 years technical writing experience
3-5 years project management and scheduling experience
1-2 years working in an FDA regulated industry
Background in medical device packaging/labeling requirements
Project Management Certification