Join to apply for the Quality Specialist role at Baxter International Inc.Here, you will find more than just a job—you will find purpose and pride.OverviewPerform 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.ResponsibilitiesDevelop, implement and maintain Quality Systems and standards at CIVAReview government, regulatory and Baxter global policies to ensure 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 requiredChange 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 tasksNCR/CAPA/Exceptions: Provide support for initiation, timely completion and closure of NCR/CAPAs in Trackwise 8 and PQIs in CQI; Identify/Implement corrective and preventive actions and evaluate effectiveness; Track and trend NCRs/CAPA/exceptions; Provide appropriate product dispositionComplaints: Log and track external and B2B complaints; Liaise with Product Surveillance to process complaints; Manage the return of complaint samples; Complete evaluation of complaint samples, perform manufacturing record review and investigations as necessary; Update metricsSupplier Quality:



Ensure applicable CIVA suppliers and finished goods/materials are approved in GSQTS; Evaluate Supplier Corrective Action Report (SCAR) responses; Track timely closure ofcorrective/preventive actions; Perform PEGA sign off of new codes, as neededHold Management and FA: Facilitate timely completion for response to Hold/FA notification; Coordinate processing of products affected by Holds and/or FAs; Manage CIVA quarantine processQuality/Regulatory Audits: Host/Participate in audits at CIVA; Perform internal auditsat CIVA; Develop and conduct Quality related training programs (e.G. cGMP, GDP, SOPs); Provide Quality supportto various CIVA Projects; Perform other Quality duties as assignedEqual Employment OpportunityBaxter is an equal chance 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 AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If 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 NoticeBaxter 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.Job DetailsSeniority level: Entry levelEmployment type: Full-timeJob function: Quality AssuranceIndustries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Hospitals and Health CareRichmond Hill, Ontario, Canada

📌 Quality Specialist (Mississauga)
🏢 Baxter International
📍 Mississauga