Quality Associate

Baxter International Inc.; Alliston; On-site; CAD 97,000 - 147,000; Full time

Job summary

A leading healthcare company in Ontario is seeking a Quality and Compliance Specialist. You will ensure product and manufacturing operations conform to specifications and standards. Responsibilities include supporting quality issues, conducting compliance reviews, and engaging in continuous improvement projects. Ideal candidates will have a University Degree in a relevant scientific field and at least 3 years of experience in a manufacturing and GMP environment. The position offers competitive compensation and a commitment to employee development.

Benefits

Equitable pay practices

Transparent pay philosophy

Employee development opportunities

Qualifications

• Minimum 3 Years of experience required.
• Manufacturing and quality background.
• Previous experience in a GMP environment.

Responsibilities

• Provide technical support on review/approval of department related procedural changes.
• Support timely follow-up on quality exceptions and their preventative/corrective actions.
• Conduct documentation reviews in the plant for compliance with existing procedures.

Skills

Detail oriented

Strong written and oral communication skills

Strong analytical and problem-solving skills

Intermediate to Advanced proficiency in MS Office Suite

Education

University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering

Job description

Overview

This is whereyour 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 Baxter

You 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).

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 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

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
• 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

Pay Transparency & Compliance Language

We understand that compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated salary range for this position is $72,080 - $108,120 annually, which reflects base salary as well as estimated target payout under the Management Incentive Compensation Plan. Individual pay will be determined based upon skills, expertise and experience, and the incentive, which is contingent upon company and individual performance outcomes. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Other notices

This posting is for a current existing vacancy within our organization. We are actively seeking qualified candidates to fill this open position. If you are interviewed for this position, we will advise you within 45 days of the interview as to whether or not you were successful in obtaining the position. Information submitted as part of the job application process will be kept on file for 3 years from the date of submission in accordance with legislative requirements.

As part of our recruitment process, Baxter Corporation may use AI tools to assist screening candidates and assist in evaluating candidate qualifications. All final hiring decisions are made by the hiring manager and recruitment team.

Equal Employment Opportunity & Accommodations

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.