Labeling Assurance Specialist

Posting Date 1 month ago(4/14/2022 4:42 PM)
Requisition ID
2022-10644
Job Location(s)
Vandergrift PA United States
Travel
None
Position Type
Full Time
Company
Cook Vandergrift
Category
Engineering

Overview

The Labeling Assurance Specialist at Cook Vandergrift is responsible for supporting the design of all product labeling (including product labels and instructions for use) to meet the regulatory requirements in the markets where the products are sold.

Responsibilities

• Create and update labeling specifications for all printed product materials
• Draft label specifications for product labels
• Support implementation of new IFUs
• Assist in the graphic design of product labels and labeling materials
• 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 stakeholders to meet project deliverables
• Communicate with outside vendors to answer questions and ensure adherence to project schedules
• Assist in the routing of product labels and labeling materials for review and approval (in the PLM system)
• Confirm labeling complies with the labeling sections of regulatory checklists
• Assist with interfacing design history files (DHFs) with other labeling systems
• Support implementation of universal device identifier (UDI) labeling and direct part marking requirements

• 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

Qualifications

• Bachelors degree preferred or experience of such kind and amount as to provide a comparable background. High school diploma or GED
• Graphic design experience in a regulatory controlled industry, preferred
• General familiarity with labeling software is preferred
• Familiarity / knowledge of Adobe graphic design software
• Experience or familiarity with Good Documentation Practice preferred

• Demonstrated competency in interpretation of technical drawings, written specifications and technical standards essential
• Experience working in a highly regulated environment in accordance with Standard Operating Procedures preferred
• Proficient in MS (Word, Excel, Outlook); PLM, and Jbase; preferred but not required

 

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

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