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Sr Auditor, Quality

Req #: JR - 054322 Location Bloomington, Indiana, United States Job Category: Quality Control Date Posted: 11/15/2021

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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Sr Auditor, Quality

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

Conducts external and internal compliance audits ensuring compliance with all applicable processes, systems and provisions of the Quality System, including regulatory requirements.  

Essential Duties and Responsibilities

  • Maintain Quality Systems in accordance with applicable regulatory requirements.
  • Prepare for Internal and Client audits by researching background information, including previous audit results.
  • Perform internal audits by collecting and analyzing objective evidence regarding issues and risks. Report findings to management team.
  • Host routine audits conducted by the company's contract manufacturing clients.
  • Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Communicate issues to management team.
  • Manage the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of audit-related corrective and preventive actions.
  • Manage the assessment file through the process to closure.
  • Perform follow-up audits to confirm corrective and preventive action is effective.
  • Remain current in regulatory knowledge through attendance at related conferences, seminars, meetings, and other training methods such as independent study of periodicals, Internet or other literature.
  • Support and participate with management during external regulatory and corporate inspections as needed.
  • Prepare management reports depicting trends for management review purposes.
  • Conduct and report on gap assessments against regulations, regulatory findings, and Corporate procedures.
  • Perform supplier quality responsibilities as applicable to local site.
  • Perform Compliance/Standards Impact Analyses for Change Control.
  • Perform Quality approval and Periodic Review for Standard Operating Procedure revisions that impact Compliance.
  • Participate in continuous improvement initiatives.

Qualifications

  • Extensive working knowledge of applicable quality and regulatory standards and regulations.
  • Excellent communication skills – both written and oral.
  • Work effectively independently and in team environment.
  • Must demonstrate sound judgment and analytical skills to enable assessment of risk.
  • Expertise in GMP regulations (21 CFR Parts 11, 201/211, EudraLex Volume 4, PIC/S PE-0015.
  • Ability to demonstrate strong organizational skills.
  • Good working knowledge of Windows based applications.
  • Resourceful, self-reliant, self-motivated and confident.
  • Working knowledge of quality software system (e.g. TrackWise).
  • General knowledge of Lean Six Sigma and other continuous improvement tools.

Education and/or Experience

  • Bachelor degree in a scientific discipline required
  • ASQ and/or RAB auditor accreditation is strongly preferred.
  • Minimum of 5 years of related Quality auditing experience in cGMP environments with particular experience in pharmaceutical aseptic manufacturing.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.

054322

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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