Raynham, MA
Date Posted: September 22, 2017
Employment Type: Contract To Hire
Job Id: 7915

Job Description

Labeling Coordinator

TTP – Just opened up today

PURPOSE:

  • Support the creation of product and packaging labels for compliance with notified body, FDA, and ISO requirements as well as companies own labeling policies and procedures.

GENERAL RESPONSIBILITIES:

  • Design and maintain regulatory compliant label content as required for R&D Programs.
  • Work collaboratively with Engineering, Marketing, Sales, Operations and Regulatory to create labeling for new product development and sustaining projects compliant with current standards.
  • Work collaboratively with Engineering, Marketing, Sales, Operations and Regulatory to make changes to existing label formats for new product development and sustaining projects compliant with current standards.
  • Assure that the label content review and approval process is comprehensive and consistently executed.
    • Create label drawings utilizing SolidWorks as required.
    • Create and process through to completion and DCRs to release new and revised labeling into Quality System.
  • Coordinate translation and outside design services for Instructions for Use and labels as necessary to meet product distribution requirements.
  • Create and maintain Standard Operating Procedures (SOP) and General Procedures (GP) relating to Labeling and other areas as needed.
  • Additional duties may include:
    • Supporting the Document Control process per SOP-401, Document Control, including, but not limited to:
    • Review Document Change Requests (DCR’s) packages to ensure all processed documents comply with policies and procedures.
    • Update Bill of Materials (BOM) as required per DCR.
    • Ensure DCR training and implementation plans are complete, and notification of approved and closed DCR’s is communicated in a timely manner as required per DCR.
    • Ensure released documents are copied to the S drive and that the latest released version of all documents is readily available to the user.
    • Review SolidWorks Drawings and Files as required per DCR.
    • Ensure quality records, including master hard copies are maintained per policies and procedures.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Knowledge of the following software programs: 
    • Bartender and/or other labeling software packages
    • Adobe CS Suite, (InDesign, Illustrator; Acrobat)
    • Microsoft Office, (Excel, Microsoft Project)
    • Access
  • Ability to communicate effectively with a broad spectrum of people having varying backgrounds, education, and experience
  • Strong organizational and project management skills a plus
  • Knowledge of Document Control and Engineering Change Systems a plus
  • Working knowledge of ISO 13485 and FDA 21CFR Part 820, MDD and CMDR
  • Working knowledge of electrical and mechanical design

EDUCATION AND EXPERIENCE:

  • Associate’s Degree in a Graphics or Technical field or equivalent combination of education and work-related experience

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