Quality Specialist - CIVA

Baxter International; Mississauga; On-site; CAD 60,000 - 80,000; Full time

Job summary

A global healthcare leader in Mississauga is seeking a Quality Assurance professional. You will ensure compliance with regulatory requirements, manage complaints, and support validation processes. Ideal candidates should have a B.Sc. in Science or Engineering, relevant QA experience, and strong analytical skills. This role offers the opportunity to make a significant impact in healthcare delivery.

Qualifications

• Relevant QA work experience in a GMP regulated industry.
• Experience in validation, sterile compounding, aseptic processing.
• Ability to work autonomously.

Responsibilities

• Ensure compliance with quality management system requirements prior to product release.
• Log and track external and B2B complaints.
• Provide support for the initiation and closure of Operations NCR/CAPAs.

Skills

Strong problem-solving

Critical thinking

Analytical skills

Ability to prioritize multiple tasks

Excellent communication skills

Self-driven for quality improvement

GMP knowledge

Lean or Six Sigma

Education

B.Sc. in Science or Engineering

Job description

Overview

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 Baxter

Ensure compliance to all applicable Regulatory, and Baxter Quality Management System requirements prior to product release.

• Collaborate with Operations to assess quality risk and address compliance gaps.
• Lead resolution of daily operational quality issues and provide product disposition in a timely manner.
• Apply expertise in critical production areas to ensure timely and efficient product release.
• Maintain audit-ready state and host/participate in internal and external audits.
• Provide Quality support to CIVA projects
• Perform other Quality duties as assigned

Validation

• Create validation packages for systems, processes and equipment to demonstrate a validated state of control
• Write protocols, coordinate validation activities, compile and analyze data, and prepare validation reports
• Provide guidance and assistance on validation formats, requirements and procedures as a team member on various validation projects
• Execute periodic reviews to ensure validated state is maintained on an ongoing basis

Change Control

• Initiate/Assess/Track Change Controls in Trackwise 8
• Review Change Control documentation for new service codes
• Manage document change control process in TcU
• Own Change Control records and tasks

Complaints

• Log and track external and B2B complaints
• Liase with Product Surveillance to effectively process complaints
• Manage the return of complaint samples
• Complete evaluation of complaint samples, perform manufacturing record review and investigations, as necessary
• Update metrics

NCR/CAPA

• Provide support for the initiation, timely completion and closure of Operations NCR/CAPAs in Trackwise 8 by owning or approving records as needed
• Collaborate with Operations to identify and implement corrective and preventive actions and evaluate effectiveness
• Provide appropriate product disposition for impacted product

Support implementation of new business/new admixtures and product/process changes at CIVA

• Complete Quality assessments and identify required tasks to implement changes
• Complete assigned change control tasks in a timely fashion

Qualifications

• B.Sc. (Science or Engineering)
• Relevant QA work experience in a GMP regulated industry / Quality Operations / Pharmaceutical applications
• Experience in validation, sterile compounding, aseptic processing
• Strong problem-solving, critical thinking and analytical skills
• Ability to prioritize multiple tasks
• Self-driven to initiate and implement continuous quality improvement
• Excellent written/oral communication and organizational skills
• Ability to work autonomously
• GMP knowledge and experience
• Knowledge of parenteral products and their intended use
• Lean or Six Sigma

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.

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