Research Associate II, Design Quality

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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

Research Associate II, Design Quality

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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.

Responsibilities:

Major responsibilities are as mentioned below but not limited to,

Review and approval of technical documents of GPRD which includes analytical and formulation documents.
Perform tool based investigations for CMO, R&D, plant, and contract labs to ensure compliance with cGxP regulations and guidelines.
Review and approve QMS documents such as change controls, investigations, and audit reports in TrackWise.
Handle market complaints and manage the quality management system (change control, CAPA, deviations, OOS, etc.).
Coordinate with external/internal auditors and ensure timely closure of audit findings.
Provide expert advice on cGxP regulations and guidelines.
Prepare, review, and implement SOPs.
Carry out internal quality audits of R&D lab and maintain Good Laboratory practices.
Review and approval of risk assessments for commercial product support.
Risk management, human factor, accelerated aging study, pFMEA, distribution study, sterilization assurance, etc. documents review.
Monitor and evaluate the performance of process and analytical methods to identify any issues or deviations.
Collaborate with other departments to ensure that all methods and procedures are compendial compliant.
Represent subject matter expertise in the areas of process and Analytical (Validation, Verification, and Transfer) as a Quality SME internally and externally as needed.
Compliance verification through GEMBA walks.
Handling of SNC’s (Supplier Notification of change).
Review and approval of Packaging development documents and data along with procedures.
Review and approval of registration and commercial stability data along with trend analysis.

Requirements:

Master or Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related field.
At least 8-15 years of experience in Quality Assurance or related field.
In-depth knowledge and understanding of cGxP regulations and guidelines.
Excellent communication and interpersonal skills.
Strong technical knowledge, investigational and problem-solving skills.
Ability to work in a team environment.
Proficient in Microsoft Office and other quality management systems.
Proficiency in Microsoft Office and TrackWise8.
Continual system improvement and cGxP mindset

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

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Tower A Ground Floor
Tower B 21st and 22nd Floor
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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.”

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.”

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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Research Associate II, Design Quality

Overview

Success Profile

Research Associate II, Design Quality

Address

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Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

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Join Our Talent Community