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Documentation Labeling Specialist

Req #: JR - 126351 Location: Castlebar, Connaught, Ireland Job Category: Quality Date posted: 04/08/2024

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Documentation Labeling Specialist

Vantive: A New Company Built On Our Legacy

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

Life Assurance

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

126351

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.

Christelle

Meet Lorena, Senior QA Associate in London, UK

I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.

Lorena

Meet Gary, Quality Research Manager in Singapore

I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.

Lorena

Meet Lorena, Senior QA Associate in London, UK

I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.

Gary

Meet Gary, Quality Research Manager in Singapore

I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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