Quality Specialist

Baxter
$46,273 - $58,592 a year
Mississauga, Ontario
Full time
2 days ago

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Product Release

Provide support for the following activities within the Quality department

  • Product Release including:
    • Review of laboratory documentation, transportation and warehouse receiving documentation
    • Disposition of imported and domestic product
    • Communicate and collaborate with 3PL on issues, deviations and corrective/preventative actions related to product distributed in Canada.
    • Communicate and collaborate with Quality Associates/Specialists/Sr. Specialists and manufacturing sites on issues, deviations and corrective/preventative actions related to product distributed in Canada.
    • Communicate and collaborate with laboratories to ensure product is tested and results are provided in a timely manner.
    • Communicate any issues that could impact product supply to Quality partners.
    • Manage and maintain all quality documents.

Compliance

  • Manage Quality responsibilities associated with product compliance including but not limited to review and/or approval of compliance documentation such as APQR, Batch records, stability data, master manufacturing/packaging documentation.
  • Provide support for method transfers, as required
  • Provide review and support of tasks related to launch of new products, as required.

Complaints

  • Perform distribution evaluations for complaints that require CA distribution assessment
  • Coordinate complaint responses from the 3PL for CA distribution.

Field Actions (FA)

  • Provide support for all activities related to Field Actions from escalation to closure, including but not limited to:
    • Ensuring accurate and timely execution of Field Action notices
    • Maintenance of FA records in compliance with corporate and MoH regulatory requirements

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.

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