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Quality Specialist II - Operations

Req # JR - 172398 Location Mississauga, Ontario, Canada Job Category Quality Date posted 06/13/2025
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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 Specialist II - Operations

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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.

Your role at Baxter

This position is responsible for ensuring that CIVA is compliant with NAPRA, cGMP, applicable license(s) and the Baxter Quality Management System. As the Sterile Compounding Supervisor, this position develops, organizes and oversees all activities related to sterile-preparation compounding. This role will be primarily focused on Quality Operations, while supporting Quality Systems.

What you will be doing

  • Collaborate with Operations to assess quality risk and address compliance gaps.
  • Lead resolution of daily operational quality issues and provide product disposition in a timely manner.
  • Apply expertise in critical production areas to ensure timely and efficient product release.
  • Maintain audit-ready state and host/participate in internal and external audits.
  • Provide Quality support to CIVA projects
  • Perform other Quality duties as assigned

Sterile Compounding Supervisor

  • Perform all functions of Sterile Compounding Supervisor per NAPRA Model Standards for Pharmacy Compounding of Hazardous/Non-Hazardous Sterile Preparations
  • Main point of contact for all communications with OCP
  • Lead execution of and response to annual OCP inspection
  • Assess proposed changes for compliance to NAPRA requirements
  • Review and approve semi-annual cleanroom/PEC certifications, daily/weekly/monthly cleaning logs, semi-annual process simulations, monthly EM trend report

Complaints

  • Log and track external and B2B complaints
  • Liase with Product Surveillance to effectively process complaints
  • Manage the return of complaint samples
  • Complete evaluation of complaint samples, perform manufacturing record review and investigations, as necessary
  • Update metrics

NCR/CAPA

  • Provide support for the initiation, timely completion and closure of Operations NCR/CAPAs in Trackwise 8 by owning or approving records as needed
  • Collaborate with Operations to identify and implement corrective and preventive actions and evaluate effectiveness
  • Provide appropriate product disposition for impacted product
  • Support implementation of new business/new admixtures and product/process changes at CIVA
  • Complete Quality assessments and identify required tasks to implement changes
  • Complete assigned change control tasks in a timely fashion

What you will bring

  • B.Sc. (Pharmacy or Microbiology)
  • Pharmacist or Pharmacy Technicial registered with Ontario College of Pharmacists
  • Strong problem-solving, critical thinking and analytical skills
  • Ability to prioritize multiple tasks
  • Self-driven to initiate and implement continuous quality improvement
  • Excellent written/oral communication and organizational skills
  • Ability to work autonomously
  • Trained in compounding of sterile preparations
  • Technical expertise in aseptic processing/technique
  • Experience in supervising sterile compounding activities
  • Relevant QA
  • GMP knowledge and experience
  • Knowledge of parenteral products and their intended use
  • Lean or Six Sigma

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 6975 Creditview Road, Unit #3
Mississauga, ON L5N 8E9
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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