Quality Assurance Officer (F/M)

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. 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 role in Quality makes a difference. Quality team members either build new processes or tackle new production challenges. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. The Quality Specialist (12-month assignment) is responsible for supporting the major Quality Systems and ensure a state of compliance and continuous improvement with product release, annual compliance, field actions/product holds, training and change control.

Disposition of both imported and domestic products
Manage and maintain all quality documents
Conduct impact assessments and complete tasks for change controls
Review and approve compliance documentation such as APQR, batch records, and stability data
Assist with product holds and quality assessments of returned products
Participate in internal audits and regulatory inspections to ensure compliance

Drug and/or medical device product release/product disposition experience
Strong communication and technical writing skills
Ability to take initiative and multitask across projects
Experience with third-party logistics and quality frameworks such as NCR/CAPA, Change Control, and Documentation
Skills in MS Office and Windows operating systems

University Degree in Sciences/Health Sciences or equivalent experience, supplemented by further post-graduate education
Experience in Pharmaceutical Quality Assurance, Chemistry, Biology, or Engineering
Prior experience with Corporate and/or MoH audits
Strong understanding of Health Canada GMP & Medical Device Regulations
Project Management experience
Decision-making skills for ambiguous situations and customer focus

Individual pay will be determined based upon skills, expertise and experience, and the incentive, which is contingent upon company and individual performance outcomes. 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.

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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