Label Compliance Specialist

4 weeks ago

Kalamazoo, Michigan, United States Eurofins Lancaster Laboratories Full time

Job Title: Label Compliance Associate

Job Summary:

We are seeking a highly skilled Label Compliance Associate to join our team at Eurofins Lancaster Laboratories. As a Label Compliance Associate, you will play a critical role in ensuring that our products meet the highest standards of regulatory compliance.

Key Responsibilities:

  • Liaise with project teams, commercial colleagues, manufacturing, and in-country regulatory affairs managers to ensure alignment on content and subsequently thorough review of drafts to provide accurate editor's copies to the company artwork center.
  • Facilitate translation with internal partners and review of translations by in-country regulatory affairs managers.
  • Utilize checklist and Outline of Production to ensure label compliance with USDA and global regulatory expectations.
  • Generate new or revised editor's copies of labels.
  • As applicable, utilize company systems for entry and tracking of regulatory activities.
  • Manage and communicate accurate timelines for deliverables including use of Asana for regular updates.
  • Train others on aspects of the global procedures necessary for stakeholders to fulfill their role in the artwork process, e.g., ensure others have sufficient knowledge of how to complete artwork request forms, prerequisites, and impact of sudden changes to the artwork on overall timeline.
  • As needed, coordinate multi-disciplinary meetings to ensure alignment on the artwork requests and to resolve complex issues.
  • Participate in and/or lead efforts continuous improvement efforts, e.g., review, revise, and/or create new artwork global work instructions for specialized situations, such as instrument related artwork, or online instructions.
  • Manage challenging situations including contributing to decisions related to escalation to leadership and/or requests for acceleration.

Requirements:

  • Bachelor's in relevant discipline.
  • Prior product label experience is preferred.
  • Knowledge of SAP, Veeva Vault, and Trackwise preferred.
  • Strong verbal and written communication and organizational skills.
  • High level of competency using Microsoft Office suite, Microsoft Word, Excel, and Adobe Acrobat.
  • Ability to effectively communicate in English with colleagues at all levels of the organization.
  • Attention to detail to ensure all expectations for labels are met.
  • Flexibility and capacity to handle multiple tasks at once.
  • Demonstration of highly effective teamwork, passion, 'can-do' attitude, and enthusiasm.
  • Consistently models behaviors of accountability, approachability, and ownership.
  • Ability to work independently, while fostering good working relationships across physical distance.
  • Capability of supporting colleagues/teams in a multicultural, dynamic, and constantly changing learning environment.

Additional Information:

This is a full-time position, Monday through Friday, 8:00am-5:00pm. Candidates currently living within a commutable distance of Kalamazoo, MI are encouraged to apply.

We offer an excellent full-time benefits package.

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