Label Compliance Associate at Eurofins Lancaster Laboratories Professional Scientific Services, LLC in Kalamazoo, Michigan

Job Description:

Company Description



The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.


Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.


If you're looking for a rewarding career, a place to call home, apply with us today!



Job Description

• 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.

• 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 in various 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.

• Position is full-time, Mon-Fri 8:00am-5:00pm. Candidates currently living within a commutable distance of Kalamazoo, MIare encouraged to apply.
  
  
  
  
  • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
  
  
  • Life and disability insurance
  
  
  • 401(k) with company match
  
  
  • Paid vacation and holidays
  
  
  
  

• #LI-EB1