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Project Coordinator

Company: Rangam Consultants Inc.
Location: Irvine
Posted on: May 14, 2022

Job Description:

  • This position is responsible for labeling project management and initiating labeling artwork change requests within a cross functional environment and subject matter expert on regulatory and commercial labeling considerations.
  • The position will lead workflow coordination within labeling management and has responsibility for key tasks within labeling artwork projects specific to redlining and commodity code assignment.
  • Will function as subject matter expert within Labeling Operations and liaise primarily with Regulatory Affairs, Packaging Engineering and Manufacturing Site Planners.
  • Ensure tasks are completed according to Right First-Time principles.
  • Collaborate closely with Artwork Development team in support of labeling artwork development and proofreading. -RESPONSIBILITIES:
    • Initiate labeling artwork change request/briefs and coordination within an artwork management system to ensure on time completion
    • Complete redlining, and input tasks in the artwork management system
    • Act as primary contact for stakeholders during labeling development to resolve any issues and provide support where needed to ensure workflow schedule is maintained
    • Manage the labeling development and implementation schedule to meet established timelines and negotiate exceptions to planned delivery dates
    • Key liaison and subject matter expert for packaging and labeling between labeling management team and the Client packaging plants and Third-Party packaging plants
    • Complete labeling change documents for implementing changes into production
    • Support coordination of regulatory submission required commodity samples -QUALIFICATIONS:
      • Bachelor's Degree in Business/Engineering/Regulatory Sciences preferred. Equivalent successful industry experience (minimum 3 years) can be considered
      • Labeling experience in Pharmaceutical or Biotech industry. Minimum of 3 years combined experience from the following areas: Quality/Regulatory, Operations, Pharmaceutical Regulations.
      • Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance.
      • Demonstrate ability to work in a highly cross functional and global environment
      • Ability to motivate and influence others
      • Knowledge of applicable regulations and standards affecting Pharmaceutical products, specifically regulations and standards affecting the Packaging and Labeling Quality System.
      • Self-motivated and strong focus on details and accuracy
      • Strong written and interpersonal communication skills

Keywords: Rangam Consultants Inc., Irvine , Project Coordinator, Other , Irvine, California

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