Associate-I, Quality Assurance Weekend night shift (Thu to Sun 23:00 to 09:00, 4 X 10 hours)

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.

We are looking for an Associate-I, Quality Assurance Weekend night shift (Thu to Sun 23:00 to 09:00, 4 X 10 hours).

Your role at Baxter

Maintain Quality and Compliance by ensuring that product and manufacturing operations adhere to Specifications, Standard Operating Procedures, and Regulatory Standards (Health Canada & FDA).

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 shifts, with the 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 the release process by performing final release of products to distribution by ensuring the product conforms to specifications, SOPs, and regulatory requirements.
• Support Quality IT Systems (SPC Infinity, EBR, BMTCS, etc.).
• Align with Regulatory and Compliance requirements by controlling defective WIP materials, including quarantine, retention, and disposal areas. Ensure adequate segregation, movement, documentation, and timely follow-up within the plant.
• Ensure shop floor presence by performing process walkabouts and supporting operations to remediate issues that are identified.
• Maintain data on critical metrics for Quality operations and Management review.
• 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.
• Review plant documentation for compliance with procedures and instructions. Verify efficiency against Baxter Corporate 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.
• Lead and participate in continuous improvement projects with the objective of achieving quality, reliability, and cost improvement goals.
• Support audits with regulatory authorities on quality and compliance issues.
• Support an Audit ready state by performing GEMBAs and following up with area owners to ensure timely closure of observations.
• Other tasks, as assigned.

What you'll have:

- University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering / ASQ certification, other Quality Certification preferred or Combined Equivalent in Work Experience.

• Minimum 3 Years of experience required.
• Manufacturing and quality background.
• Previous experience in a GMP environment.
• Knowledge of cGMP, ISO, and Regulatory standards.
• Diligent 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 positive relationships and collaborate with collaborators, customers, and team members.
• 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 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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