SUMMARY OF RESPONSIBILITIES Responsible for maintaining Quality and Compliance by ensuring product and manufacturing operations conform to Specification, Standard Operating Procedures and Regulatory Standards (Health Canada & FDA).
ESSENTIAL DUTIES AND RESPONSIBILITIES 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 on assigned shift, with requirement to support plant overtime and planned shutdowns when applicable. Support to other shifts will be required to add coverage as necessary
Provide technical support on review/approval of department related procedural changes product quality issues, reinspection, new product introduction and Protocols
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/investigation and approvals of non-conformance events in the Trackwise system
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, BMTCS, 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
Maintain Quality operations KPIs and Management review data




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 Non-conformance/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
Other tasks, as assigned
JOB REQUIREMENTS 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 – 5 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
Equal Employment Chance Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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.
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📌 Quality Associate-I, QA Assurance- Night shift (Sunday to Thursday) (Ontario)
🏢 Baxter International
📍 Ontario