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Quality Specialist, Product Release

https://www.baxter.com/ Logo

Baxter

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Location:
Canada , Mississauga, Ontario

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Contract Type:
Not provided

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Salary:

72080.00 - 108120.00 CAD / Year

Job Description:

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. The Quality Specialist (12-month assignment) is responsible for supporting the major Quality Systems and ensure a state of compliance and continuous improvement with product release, annual compliance, field actions/product holds, training and change control.

Job Responsibility:

  • Review laboratory, transportation, and warehouse documentation to ensure product release
  • Disposition of both imported and domestic products
  • Work together with 3PL and internal teams on matters and steps related to product distribution in Canada
  • Manage and maintain all quality documents
  • Conduct impact assessments and complete tasks for change controls
  • Review and approve compliance documentation such as APQR, batch records, and stability data
  • Support method transfers and the launch of new products as required
  • Assist with product holds and quality assessments of returned products
  • Participate in internal audits and regulatory inspections to ensure compliance

Requirements:

  • University Degree or equivalent experience and/or relevant post-secondary education and experience
  • Drug and/or medical device product release/product disposition experience
  • Excellent knowledge of GMPs and Health Canada regulations
  • Strong communication and technical writing skills
  • Ability to take initiative and multitask across projects
  • Experience with third-party logistics and quality frameworks such as NCR/CAPA, Change Control, and Documentation
  • Skills in MS Office and Windows operating systems

Nice to have:

  • University Degree in Sciences/Health Sciences or equivalent experience, supplemented by further post-graduate education
  • Experience in Pharmaceutical Quality Assurance, Chemistry, Biology, or Engineering
  • Prior experience with Corporate and/or MoH audits
  • Strong understanding of Health Canada GMP & Medical Device Regulations
  • Project Management experience
  • Decision-making skills for ambiguous situations and customer focus
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
February 18, 2026

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