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Quality Associate II

Req # JR - 163875 Location Alliston, Ontario, Canada Job Category Quality Date posted 03/06/2025
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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

Quality Associate II

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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.

Position Summary

Join a team that values precision, innovation, and collaboration at Baxter Healthcare Corporation.

Responsibilities:

  • Work closely with cross-functional teams, including IT, product management, engineering, and business collaborators, to establish quality goals and needs.
  • Conduct risk assessments and identify potential areas for improvement in digital systems, processes, and workflows, partnering with IT as needed based on system architecture.
  • Provide frontline day-to-day support on product quality issues to ensure GMP, regulatory, and procedural compliance, maintaining flawless standards of quality.
  • Support during assigned shifts, including the requirement to support plant overtime and planned shutdowns when applicable, with the flexibility to cover other shifts as necessary.
  • Provide technical support on review/approval of department-related procedural changes, product quality issues, reinspection, new product introduction, and protocols.
  • Ensure timely follow-up on quality exceptions and their preventative/corrective actions.
  • Initiate, investigate, and approve non-conformance events in the Trackwise system.
  • Serve as the SME for Electronic Batch Record (EBR) and Statistical Process Control (SPC) systems.
  • Perform change control assessments, executions, and approvals.
  • Support Quality IT Systems (SPC Infinity, EBR, BMTCS, Maximo, etc.).
  • Maintain control of defective WIP materials (quarantine, retention, and disposal areas) to align with regulatory and compliance requirements.
  • Maintain data on critical metrics for Quality operations and Management review.
  • Train, mentor, and guide Associates I to achieve defined quality goals and results, facilitating development and ensuring compliance with set standards.
  • Use trending reports of quality exceptions to partner with production personnel, determining opportunities to improve processes and reduce exceptions.
  • Support complaint and CAPA investigations as required.
  • Conduct documentation reviews and approvals in the plant for compliance with existing procedures and instructions, verifying the efficiency of these procedures against Baxter Corporate and Regulatory Requirements.
  • Maintain Alliston files in accordance with the Quality Retention Policy.
  • Support and lead the weekly/daily Tier/Release meetings to present quality and compliance issues.
  • Lead and participate in continuous improvement projects aimed at achieving quality, reliability, and cost improvement goals.
  • Act as SME for assigned processes during internal/external audits with regulatory authorities.
  • Support an audit-ready state by performing GEMBAs and following up with area owners to ensure the timely closure of observations, working with operations to remediate issues.
  • Act as a delegate for the Quality Operations Manager when required.
  • Perform other tasks as assigned.

Knowledge, Skill and Abilities

  • Detailed knowledge of drug regulations and standards.
  • Strong analytical, critical thinking, and problem-solving skills.
  • Excellent communication and leadership abilities.
  • Strong interpersonal, influencing, and negotiation skills.
  • Proven project management skills.
  • Ability to analyze risk and make informed decisions.

Required Education and Experience

  • Bachelor’s degree in engineering, biochemistry, microbiology, or a related field; a master’s degree is preferred.
  • A minimum of 3 years of experience in quality assurance.
  • Experience in project management.

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 89 Centre Street South
Alliston, ON L9R1W7
Canada 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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