Location: Irvine, CA/hybrid
Schedule: Standard Office Hours
Duration: 12-Month Contract
Pay range: $45.00 - $50.00 per hour


Role Purpose:

Responsible for ensuring that all tasks related to updates or changes to global labeling standards and procedures, training plans, process improvements, and the routing and approval of assigned labeling deliverables through ECR and PDM processes are conducted in compliance with relevant standards and regulations.


Essential Job Functions:

• Execute complex label change packages (e.g., ECO, mass updates, redlines, ECR generation and processing, compiling documentation, data entry) within and across all business units/sites with limited to no direction. Summarize and capture change intent accurately within the quality system (e.g., ECR) in adherence to GDP (Good Documentation Practices). Actively follow up on change requests (e.g., SARS, ECRs) and manage approvers to ensure timely closure
• Evaluate routine risks and provide recommendations to resolve issues
• Update more complex procedures and lead routine process improvement opportunities within scope
• Provide training and coaching to other team members

Education/Experience:

• Associate's degree or equivalent (e.g., 2 years of college coursework) with 4 years of related work experience, or
• H.S. Diploma or equivalent with 6 years of related work experience

Required Skills:

• Proficiency in using MS Office Suite
• Strong written and verbal communication skills and interpersonal relationship abilities
• Effective time management and organizational skills
• Ability to identify process improvement activities
• Proficiency in reading, comprehending, writing, and speaking English
• Thorough knowledge and understanding of policies, procedures, and requirements related to task execution within labeling operations
• Strong knowledge of labeling requirements across business units
• Thorough understanding of labeling systems and applications (e.g., ECR and PDM processes)
  

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