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Analyst, Quality Documentation

Req # JR - 157659 Location Tijuana, Baja California, México Job Category Quality Date posted 01/31/2025
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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 Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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

Analyst, Quality Documentation

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This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary
Responsible for supporting the QMS and managing the development and revision of standard procedures and training materials for a global audience. Participate and drive department assessments and assure closure to items identified. Support and lead department improvement projects through successful implementation. Must have the ability to manage projects, work in a team setting and encourage teamwork and drive decisions. Provide guidance to internal/external customers on document and system related issues. Review and approve GMP/GLP Manufacturing and related documentation to support timely product and system release.
Essential Duties and Responsibilities.

The incumbent will perform other duties as assigned.
1) Highly proficient in project and configuration management.
2) Strong technical writing skills for creating and editing content, particularly to procedures and templates that support the global Quality Management System.
3) Leading document creation and initiation activities while maintaining effective communication and developing partnerships with customers globally. 4) Provide training to internal and external personnel on documentation/labeling/archive related processes and systems. 5) Perform/assist in internal assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Maintain expertise in quality systems and quality techniques.
6) Actively participate in process improvement and the implementation of new/enhanced processes. 7) Maintain a high level of expertise in current regulatory requirements and technical issues. Participate in QA/QC multi-site projects in the role of contributor, coordinator or leader.
8) Support internal and external audit activities.

Qualifications.

  • Proficient in the document change control process.
  • Skilled in Desktop publishing, Graphics/Illustrations software and document management (e.g. Word) software applications.
  • Data/Document configuration management proficiency.
  • Facilitating training.
  • Strong project management skills.
  • Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
  • Familiarity with interpreting regulations and quality systems.
  • Understand strategies and be able to develop new businesses process/tools.
  • Good interpersonal/communication/influencing/negation skills.
  • Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Knowledge of product/document configuration management.
  • Working knowledge of related business systems.
  • Working knowledge Quality Management Systems

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.

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Address

Explore this location Emilio Flores #2471-A
Col. Cañon del Padre
22203 Tijuana, BCN
Mexico Explore This Location

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.”

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.”

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.”

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