Project Coordinator II
ATR International - Irvine, CA
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We are seeking a Project Coordinator II for a very important client.This position is responsible for labeling project execution within a cross functional environment and key subject matter expert on regulatory and commercial labeling considerations to ensure the Global Label Management organization meets its performance objectives. The position will lead workflow coordination within labeling artwork production and has responsibility for key tasks within labeling artwork projects specific to (technical) redlining and commodity code assignment. Will function as key subject matter expert within Labeling Operations and liaise primarily with Regulatory Affairs, Packaging Engineering and Manufacturing. 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:- Lead coordination within labeling artwork production in artwork management system to ensure on time completion- Complete redlining, tech doc and disposition tasks in the artwork management system- Drive exception management for artwork workflow execution.- Act as primary contact for stakeholders during artwork development, proofreading and approval 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 at company plants and Third-Party Manufacturers- Support coordination of regulatory submission required commodity samples Requirement: The ideal candidate will possess the following qualifications:QUALIFICATIONS:- Bachelor?s Degree in Business/Engineering/Sciences preferred. Equivalent successful industry experience (minimum 4 years) can be considered- Labeling experience in Pharmaceutical or Biotech industry. Minimum of 4 - 6 years combined experience from the following areas: Quality/Regulatory, Operations, Pharmaceutical/Device Regulations.- Proficient in English language- 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 over whom they have no direct authority.- Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo 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- High affinity to IT systems
Created: 2024-09-07