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Sr. Quality Specialist

Req #: JR - 062559 Location Mississauga, Ontario, Canada Job Category: Quality Control Date Posted: 04/29/2022

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. Quality Specialist

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:

In this role you will be responsible for ensuring that CIVA is compliant with cGMP, applicable license(s) and the Baxter Quality Management System. This position will direct the implementation, deployment and ongoing continuous improvement of CIVA Quality and support the management of the Baxter QMS within the compounding site. You would be responsible for ensuring compliance to all applicable Regulatory, Certified Body and Quality System requirements and also ensures appropriate risk identification processes are implemented at the compounding site.

What you'll do:

  • Responsible for the implementation of Quality Systems

  • Review, analyze and evaluate the quality system through non-conformance management, data trend analysis and routine internal audits

  • Manage the development and revision of current Standard Operating Procedures related to the Quality processes

  • Manage audit readiness state and participate in internal and external audits

  • Manages CIVA Quality KPIs and metrics and chair compliance meetings for the site

  • Ensure applicable CIVA suppliers and finished goods/materials are approved as required

  • Evaluate Supplier Corrective Action Report (SCAR) responses

  • Perform CIVA supplier quality audit as needed

  • Provide support for the initiation, assessment, approvals, timely completion and closure of NCRs and Change Controls

  • Perform the Quality Review of admixtures batch documentation for compliance with current procedures and conformance with Good Documentation Practices

  • Coordinate the processing of products or materials affected by holds and FCA

  • Support the site Escalation process with appropriate documentation and reporting

  • Identify risks on site by routine spot checks and internal audits

  • Develop risk assessments and actions plans for risk management on site

  • Manage other special projects as required, ensuring all Quality related tasks are completed in conformance with business and regulatory requirements

  • Prepare annual validation schedule and support timely completion of validation activities

  • Provide Quality Support to various CIVA projects

  • Perform other Quality duties as assigned by Manager Quality, CIVA

What you'll have:

  • Bachelor of Science Degree

  • 3+ years of relevant work experience in a GMP related industry

  • Strong problem solving, critical thinking and analytical skills

  • Ability to prioritize multiple tasks and work autonomously

  • Knowledge and application of computer systems for word processing, reporting, data analysis and NCR/CAPA, Change Control and Complaint management

  • Ability to proactively initiate and implement continuous quality improvement

  • Excellent written/oral communication and organizational skills

Nice to have:

  • Bachelor of Science Degree (Pharmacy or Microbiology) and/or Lean or Six Sigma

  • 2 or more years experience in compounding and/or pharmaceutical manufacturing

  • Knowledge of parenteral products and their intended use

  • Process control orientation

      Reasonable Accommodations

      Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] 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.

      062559

      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."

      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.

      Join Now
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