Quality Associate - Day shift

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 Job at Baxter

To provide technical expertise in the implementation, and maintenance of quality systems to ensure compliance with regulatory requirements and Baxter's quality policies. This role will play a key part in driving quality excellence and ensuring the delivery of high-quality products to our customers.

What you will be doing

Quality Systems Technical Expertise

• Provide technical expertise and guidance on quality systems, including quality management systems (QMS), document control, change control, and corrective and preventive action (CAPA) processes.

• Develop and maintain quality policies, procedures, and work instructions to ensure compliance with regulatory requirements and Baxter's quality policies.

• Collaborate with cross-functional teams to identify and implement quality system improvements.

Quality Systems Implementation and Maintenance

• Implement and maintain quality system initiatives to ensure compliance with regulatory requirements and Baxter's quality policies.

• Conduct gap assessments and risk assessments to identify areas for improvement and develop corrective actions.

• Develop and maintain quality system documentation, including procedures, work instructions, and records.

• Work with the Mississauga QA and RA teams to ensure appropriate execution of Management Review

• Manage and Maintain Canada-specific Agreements

Training and Awareness

• Develop and deliver training programs to ensure employees understand and comply with quality systems and regulatory requirements.

• Provide guidance and support to employees on quality system-related issues.

Audits and Inspections

• Lead audit readiness activities to assure Baxter Canada is in a state of audit readiness

• Participate in internal audits and regulatory inspections to ensure compliance with quality systems and regulatory requirements.

• Develop and implement corrective actions to address audit and inspection findings.

3PL Quality Systems Support

• Support the Regional Hold coordinator to assure product holds are appropriately executed.

• Conduct Quality assessments of Returned product

• undefined

What do you bring:

Bachelor of Science in Chemistry or Biology

· Knowledge of GMPs, and government regulations for drug products, biologics, and medical devices

· Prior QA experience in the Pharmaceutical Industry

· Knowledge of Canadian regulations for drug product, biologics and medical devices

· Ability to use the Microsoft Suite of applications

· Ability to build strong relationships with internal and external customers

· Ability to work independently and prioritize

· Strong data analysis and investigation skills

· Excellent communication skills

· General knowledge of Quality systems

· SOP/Technical Writing experience

· Knowledge of GMPs and Health Canada regulations for drug products, biologics and medical devices

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.