Skip to main content

Associate I, Quality Operations - Weekend Night

Req # JR - 024013 Location Alliston, Ontario, Canada Job Category Quality Control Date posted 07/15/2020

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.


Responsible for maintaining Quality and Compliance by ensuring product and manufacturing operations conform to Specification, Standard Operating Procedures and Regulatory Standards (Health Canada & FDA).


  • Provide front line day to day support on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality
  • Support the day shift, with requirement to support plant overtime and planned shutdowns when applicable
  • Provide technical support on product quality issues
  • Partner with Quality and Production personnel to ensure mitigating actions are identified and implemented
  • Support timely follow-up on quality exceptions and their preventative/corrective actions
  • Support initiation of new non conformance events in the Trackwise system as required
  • Support release process by performing final release of products to distribution by ensuring product conforms to specifications, SOPs and regulatory requirements
  • Support Quality IT Systems (SPC Infinity, EBR, etc.)
  • Ensure control of defective WIP materials (quarantine, retention and disposal areas) to ensure adequate segregation, movement, documentation and timely follow-up within the plant to comply with Regulatory and Compliance requirements
  • Ensure shop floor presence by performing process walkabouts and supporting operations to remediate issues that are identified
  • Use trending reports of quality exceptions to partner with Production personnel to determine opportunities to improve processes and reduce exceptions
  • Support complaint and CAPA investigations, when required
  • Conduct robust DMAIC Nonconformace/CAPA investigations, when required
  • Conduct documentation reviews in the plant for compliance with existing procedures and instructions, and verify the effectiveness of procedures and instructions versus Baxter Corporate requirements and Regulatory Requirements
  • Maintain Alliston files in accordance with the Quality Retention Policy
  • Attend the weekly/daily Tier meetings to present quality and compliance issues
  • Leads and participates in continuous improvement projects with the objective of achieving quality, reliability and cost improvement goals
  • Supports audits with regulatory authorities on quality and compliance issues
  • Supports an Audit ready state by performing GEMBAs and following up with area owners to ensure timely closure of observations
  • Provide support for the Quality Technical review/approval of department related procedural changes
  • Other tasks, as assigned


  • University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering
  • ASQ certification, other Quality Certification preferred
  • Manufacturing & Quality background
  • Previous experience in a GMP environment
  • Knowledge of cGMP, ISO and Regulatory standards
  • Experience: 1 – 3 years
  • Detail oriented with the ability to work under pressure
  • Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
  • Ability to build strong relationships and partner with internal and external stakeholders.
  • Strong ability to balance multiple priorities.
  • Strong analytical and problem-solving skills with critical thinking abilities.
  • Intermediate to Advanced proficiency in MS Office Suite
  • Preferred: Experience with continuous improvement methodologies, Lean 6S, Kaizen, TPM, DMAIC

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 and let us know the nature of your request along with your contact information.

Join Our Talent Community

This website is owned and operated by Baxter Healthcare Corporation [One Baxter Parkway, Deerfield, IL 60015-4625] ("Baxter") acting as data controller for itself and on behalf of all of its affiliates and subsidiaries. By clicking on the “Subscribe” button I declare that I have read the Privacy Policy and consent to Baxter processing my personal data for the purposes of joining the Baxter Talent Community: to provide me via email with job offers in the area of my interests and to provide me information about Baxter. I am aware that I have the right to withdraw my consent by clicking the “Unsubscribe” option in the emails I receive from Baxter.

Select InterestsSelect a job category from the list of options. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

    You have not recently viewed any jobs.

    You have not saved any jobs.