Quality Associate-I, QA Assurance- Night shift (Sunday to Thursday)

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. 

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 Opportunity

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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .