This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
Your role at BaxterYou will be responsible for maintaining Quality and Compliance by ensuring product and manufacturing operations conform to Specifications, Standard Operating Procedures and Regulatory Standards (Health Canada & FDA).
The shift time for this position is Midnight shift (Sunday to Thursday 23:00h-7:30h EST)
What you'll be doing:- 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 (Exception, Deviations, Document Approvals, etc.)
- 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