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Associate III, Quality Lab – Validation Analytics

Req #: JR - 041217 Location Marion, North Carolina, United States Job Category: Quality Control Date Posted: 06/16/2021

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.

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  • 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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Associate III, Quality Lab – Validation Analytics

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. 

Job Title:  Associate III, Quality Lab – Validation Analytics

Position Summary

Responsible for performance and efficiency of Analytical Validation and Qualification activities. Lead and/or coordinate activities in support of analytical validation operations to ensure: safe operations, effective planning, and regulatory compliance in the performance of method, process, cleaning, and stability validations for various chemical products while maintaining high standards for quality and responsiveness to production requirements.

Job Responsibilities

  • Create validation packages for systems, processes, cleaning procedures, analytical methods, and laboratory equipment to demonstrate a validated state of control.
  • Write protocols, manage the execution of validation testing plans by liaising with other department to coordinate validation activities, compile and analyze data, and prepare validation packages
  • Coordinate IQ/OQ/PQ activities with Production, Quality Control Laboratories, outside contractors, corporate engineering, and other validation groups.
  • Responsible to be a subject matter expert for lab equipment, practices, and methods as they pertain to execution of special testing protocols and validations.
  • Monitor and support the execution of the protocols through training, facilitating, and problem solving activities.
  • Provide guidance and assistance on validation formats, requirements, and procedures as a team member on various protocol projects.
  • Support training for team members and provide resource information as a technical expert.
  • Review completed protocols and testing packages for compliance with quality and regulatory requirements.
  • Support/participate in the mixing, flush and cleaning validation programs.
  • Contribute/participate in facility Quality review meetings.
  • Participate as the Validation SME during regulatory and Corporate compliance inspections.
  • Participate in quality assessments of internal operations and suppliers, to analyze compliance and assess risk.
  • Write, revise and approve Standard Operating Procedures
  • Sustain a clean and safe work environment utilizing 6S principles

Knowledge, Skills, and Abilities

  • Intermediate to Advanced proficiency of Microsoft office applications (Word, Excel, PowerPoint)
  • Attention to detail and strong organizational skills
  • Strong analytical and problem solving skills and critical thinking abilities.
  • Must have a strong understanding of laboratory instrumentation
  • Good documentation skills and knowledge of GDPs (Good Documentation Practices)
  • Strong ability to manage multiple tasks/priorities in a timely manner
  • Working knowledge of TrackWise system
  • Strong written and oral communications skills, negotiation skills, and ability to work with all levels of the organization.
  • Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action

Required Education and Experience

  • B.S. degree in Natural Sciences: Chemistry, Microbiology, Pharmacy, or Engineering preferred
  • Minimum of 5 years of experience or Master’s/ Ph.D. degree in Natural Sciences with 1-3 years’ experience in a GMP Laboratory, preferably in the pharmaceutical or medical device industry

Other Duties as Assigned

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.

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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.

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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.

041217

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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