Documentation Labeling Specialist

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Your role at Baxter:

At Baxter, we are committed to ensuring a first-class candidate experience and your role will be critical in enabling us to do this. This position has tremendous potential for growth.We’re searching for a Documentation/ Labelling Specialist to join our team based in Castlebar, Co. Mayo.As a member of our Quality team, the Documentation/ Labelling Specialist is responsible for maintaining a high level of documentation and labelling management and implement improvements across Castlebar and Swinford sites.You will play a key part in the quality and compliance procedures which are critical to saving and sustaining lives. You will collaborate with many other departments and teams across both Swinford and Castlebar sites.Join us and our culture of great teams whose work values include speed, simplicity, courage and collaboration.

What are your responsibilities?

• Responsible for management of new/revised labeling in line with marketing and regulatory compliance and complete all activities required for labelling updates.
• Printing of production labels as required
• Follow procedures to maintain serialisation labelling requirements as applicable.
• Process and Issue specification/ procedure changes for the site as required
• Coordinate archiving of documents
• Update Batch record parameters per procedures ( Ebatch wrappers)
• Closure of Validation protocols on Baxter Validation Data base ( VMS)
• Follow procedures to maintain current versions and labeling databases (Codesoft, Easi label, Ebatch/ Prism).
• Follow procedures to maintain current Bill of Material (Prism, Ebatch, EXPS).
• Route Labelling and associated documentation on Baxter documentation system Teamcenter (TCU).
• Identify, develop and implement best practices of the Label/ Documentation Control Function as appropriate to improve efficiency.
• Responsible for purchasing of labeling and documentation department items on Coupa.
• Perform other duties as assigned by business needs.

We are looking for people who have the following:

• Bachelor’s degree / equivalent
• Graphic Art experience ( not essential)
• Ensures accountability and plans and prioritizes commitments and is deadline driven
• Strong computer skills – Microsoft Office and Adobe Acrobat
• Familiar with FDA regulations, GMP’s and standard operating procedures
• Experience with computerized proofreading systems, documentation, product lifestyle systems, Serialisation systems, digitized artwork storage and documentation system
• Strong written and verbal communication skills
• Strong attention to detail
• Willingness to work flexible hours

• What are some of our benefits of working at Baxter?
• Pension
• Annual Bonus
• Health Insurance
• 25 Days Holidays