Quality Specialist

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Overview  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.
Responsibilities   Develop, implement and maintain Quality Systems and standards at CIVA
Review government, regulatory and Baxter global policies to ensure local procedures are current and meet requirements
Identify compliance gaps and develop plans to address gaps
Develop SOPs and ensure implementation
Manage and maintain organization of all quality documents
Prepare metrics for Monthly and Quarterly reports as required
Change 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 tasks
NCR/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 disposition
Complaints:
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 metrics
Supplier Quality:
Ensure applicable CIVA suppliers and finished goods/materials are approved in GSQTS;
Evaluate Supplier Corrective Action Report (SCAR) responses;
Track timely closure of corrective/preventive actions;
Perform PEGA sign off of new codes, as needed
Hold 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 process
Quality/Regulatory Audits:
Host/Participate in audits at CIVA;
Perform internal audits at CIVA;
Develop and conduct Quality related training programs (e.g. cGMP, GDP, SOPs);
Provide Quality support to various CIVA Projects;
Perform 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 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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Job Details   Seniority level:
Entry level

Employment type:

Full-time
Job function:
Quality Assurance
Industries:
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Hospitals and Health Care
Richmond Hill, Ontario, Canada

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