Packaging and Labeling Analyst

Highly Competitive
  1. Permanent
  2. Packaging
  3. United States
Philadelphia, Pennsylvania
Posting date: 08 Feb 2019
EN.MJ.21631_1549619259

ProClinical is recruiting for a leading workforce management solution company, who are currently seeking a Packaging and Labelling Analyst to join their team. Based in Philadelphia, the Packaging & Labelling Analyst will come up with an end-to-end plan for label and packaging solutions.

Job Responsibilities:

  • Acting as a point person for label and packaging for EU MDR within BWI.
  • Planning, executing, and communicating project and design deliverables.
  • Leading collaboration for EU MDR changes between the company's Lifecycle Product Managers, Quality, Regulatory, Marketing, and packaging associates with prioritisation and execution strategies.
  • Determining and manging file history.
  • Setting up project governance.
  • Ensuring stakeholders understand outputs of all decisions and tracking project status.
  • Maintaining product label design and process knowledge.
  • Executing Design Change documentation and execution for labelling and packaging.
  • Working with planning for phase in/phase out of changes considering commercial, quality, or regulatory strategies and insuring implementation.
  • Knowing and following local Quality System policies and procedures.
  • Completing training in area of responsibility within allowed time-period; training is required for changes in existing policies and procedures for new assignments and the implementation of new policies and procedures.
  • Following all company safety policies and other safety precautions within work areas, and promoting safety to all associates that enter work area.

Skills and Requirements:

  • A bachelor's degree, with a Project Management Professional Certification a desirable bonus.
  • At least 3 years of demonstrated experience with project/project management.
  • At least 3 years of work experience in labelling in the Medical Device industry.
  • Prior experience with EU MDR.
  • Prior experience with UDI.
  • Excellent communication skills, including conflict management, influencing, persuasion, and written and oral proficiency.
  • Technical Writing skills and experience is preferred.
  • Demonstrable track record of Leadership results, along with Change and Stakeholder Management.
  • A thorough understanding of compliance requirements for medical devices and labelling preferred.
  • Experience in Labelling Design and development process, along with Design and Change Control.
  • Knowledge of the PLM System and ERP System.
  • An understanding of Manufacturing Packaging and Labelling processes.
  • Business and financial acumen.
  • Demonstrable leadership of projects across quality systems, plants, and regions preferred.
  • An ability to work with Management in a matrix environment.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Mary Jacobs on +44 267-477-4800 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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