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Quality Analyst

Req #: JR - 132714 Location: Santiago de Cali, Departamento del Valle del Cauca, Colombia Job Category: Quality Date posted: 04/16/2024

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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Quality Analyst

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.

Your role at Baxter:

The Quality Analyst plays a key role in supporting the external contract manufacturing Quality organization at Baxter by:

What you'll be doing

1• Review and approve manufacturing records (batch and DHR records) for products manufactured by other Manufactures suppliers Organizations to ensure accuracy and completeness. This may include a review of Minor nonconformance reports related to the manufacture of these products.

2 • Generate Baxter Certificates of Conformance and Certificates of Analysis (CoC/CoA) for these products when required.

3 • Apply systems (e.g., JDE, Bot, SharePoint) for crafting and storing quality records.

4 • Use electronic systems (e.g., Trackwise) for maintaining supplier quality records and uploading requirements.

5 • Assist with periodic supplier requirement reviews by confirming and/or acquiring quality requirements such as quality agreements, surveys, or quality certificates.

6 • Assist with supplier-related change control tasks as assigned/required.

7 • Assist with controlled document revisions as needed.

8 • Assist with automated Bot performance monitoring (and associated IT validation activities as required).

9 • Support supplier access requests to Baxter Certificate Repository.

10 • Assist with Baxter and supplier batch record retention/archival as needed.

11 • Help with external product complaint sample shipment coordination.

12 • Participate in continuous improvement activities and projects (i.e., CAPA, Pr oduct Improvement teams). May lead projects assigned by management.

13 • Interpret and complete policies and procedures that affect the organizational unit.

14 • Interact frequently with functional peer groups, area management, and Baxter’s suppliers.

• Manage workflow: identify and raise issues as needed.

What you'll bring

1 • Bachelor’s degree in Pharmaceutical Chemistry or related

Alternately, a combination of equivalent education and experience will also be considered.

2 • (1 – 3) years of experience working in the pharmaceutical, medical device, or biotech industry preferred.

3 • Familiarity with regulatory (e.g., U.S. FDA) and ISO 13485 requirements preferred.

4 • Prior experience working with SharePoint, Microsoft Office applications, Warehouse Management system, reviewing manufacturing batch records/DHR documents, and reviewing/approving Minor nonconformance investigations related to finished goods preferred.

5 • Fluent in English (mandatory)

#LI-GR1

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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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.

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