Mississauga, Ontario
20 hours ago
Quality Specialist

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. 

Perform the quality functions at the Center for Intravenous Admixtures (CIVA) by providing support and guidance to ensure implementation of Quality System and compliance with pharmacy guidelines, Baxter global policies, SOPs and applicable regulatory requirements.Monitor compliance through ongoing reviews and implement continuous improvements.

Develop, implement and maintain Quality Systems and standards at CIVAReview government, regulatory and Baxter global policies to ensure all local procedures are current and meet requirementsIdentify compliance gaps and develop plans to address gapsDevelop SOPs and ensure implementationManage and maintain organization of all quality documentsPrepare metrics for Monthly and Quarterly reports as required

Change Control

Initiate/Assess/Track Change Controls in Trackwise 8Review Change Control documentation for new service codesManage document change control process in TcUOwn Change Control records and tasks

NCR/CAPA/Exceptions

Provide support for the initiation, timely completion and closure of NCR/CAPAs in Trackwise 8 and PQIs in CQIIdentify/Implement corrective and preventive actions and evaluate effectivenessTrack and trend NCRs/CAPA/exceptionsProvide appropriate product disposition 

Complaints

Log and track external and B2B complaintsLiase with Product Surveillance to effectively process complaintsManage the return of complaint samplesComplete evaluation of complaint samples, perform manufacturing record review and investigations, as necessaryUpdate metrics

Supplier Quality

Ensure applicable CIVA suppliers and finished goods/materials are approved in GSQTSEvaluate Supplier Corrective Action Report (SCAR) responsesTrack timely closure of corrective/preventive actionsPerform PEGA sign off of new codes, as needed

Hold Management and FA

Facilitate timely completion for response to Hold/FA notificationCoordinate processing of products affected by Holds and/or FAsManage CIVA quarantine process

Quality/Regulatory Audits

Host/Participate in audits at CIVAPerform internal audits at CIVADevelop and conduct Quality related training programs (e.g. cGMP, GDP, SOPs)Provide Quality support to various CIVA ProjectsPerform other Quality duties as assigned

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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