IrvineRecruiter Since 2001
the smart solution for Irvine jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds