Specialist-I, Quality Systems - Jobs in Alliston

Job Description

This is where you save and sustain livesAt 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 #39;ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter #39;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.Your Role at BaxterIn this role, you will be responsible for performing thorough review and approval of site Investigation records. He/ she must liaise with personnel across various functional groups to get the facts and data required to confirm investigation results and corrective actions are suitable to address root cause findings.You will be responsible for developing Annual Product Quality Review (APQR) reports and is considered the Process Owner for the Product Quality Review process. He/ she must liaise with personnel across various functional groups to get the facts and data required for the reports, analyze the data, reach conclusions, connect results to previous reports and/other interfaces, determine improvement actions commensurate to risk. The person in this role (1) owns execution of site APQR procedures, (2) drives changes as needed to ensure they incorporate cGMP expectations and are aligned to Baxter Global Processes/ Procedures, (3) ensure actions are identified based on conclusions from the product reviews.The top two priorities for all Baxter Alliston employees are Safety and Quality:Safety:Support our goal to achieve a “Zero Harm Environment”, by ensuring the safety of yourself and your co-workers through:following all safety procedures understanding potential hazards in your area wearing appropriate PPE reporting all incidents / near-misses / concerns embracing 6sQuality: Ensure the quality of our products to ensure patient safety and achieve our mission of “Saving and Sustaining Lives”.This can be achieved through:+++following Good Manufacturing Practices (GMP) +++adhering to all quality procedurescompleting training on-timeDoing it Right the First Time, andreporting any quality concerns immediately.As part of the plant’s Enterprise Management System (EMS), all employees must embrace a culture of Continuous Improvement by:participating in improvement activitiesidentifying and implementing continuous improvement ideasparticipating in Tier meetingsrecognizing your peers, andembracing 6s.An additional general expectation for the person in this role is to ensure that the culture levels of Simplification-Speed-Collaboration-Courage are demonstrated through results.Note: Accountabilities or job-duties cannot be confined to those enumerated in this or any job-description. Role (responsibilities) evolve and expand as business needs change over-time -openness, flexibility, and change-agility in relation to duties and responsibilities are central to any evaluation of successful performance.What you #39;ll be doing:Perform review and approval of NCR and CAPA (in Trackwise).Provide coaching to Operational personnel to help them become acquainted and knowledgeable about the NCRamp; CAPA workflows in Trackwise.Acts as site non conformance process owner designeeVerify corrective actions have been identified to address root causeCollaborate with site investigation owners to provide coaching on the processPromptly notify and escalate potential/ emerging significant quality/compliance issues related to Nonconformanceamp; CAPA to Quality Systems Manager and QMR.Plan and prepare annual schedule for Alliston Product Quality Reviews. Drive actions to ensure adherence to schedule.Conduct Annual Product Quality Review for all product families manufactured in the Alliston facility.Get necessary product manufacturing and testing factsamp; data, analyze the data, reach conclusions, connect results to previous reports and/other interfaces, determine improvement actions commensurate to analysis, to author APQR.Liaise with technical groups within the site (e.g., Validations) or corporate groups (e.g., PDO) as necessary to share and confirm issues that may arise, such as if atypical trends are observed.Drive changes in site APQR procedures, as needed to ensure they incorporate cGMP expectations and are aligned to Baxter Global Processes/ Procedures.Remains current with respect to regulatory trends and divisional issues.Support Inspection Readiness activities.Partners with facilities, divisions, and regions to ensure successful implementation and compliance to Global Quality Processes/ Procedures/regulations.What you #39;ll bring:University Degree, Bachelor of Science, Pharmacy or Engineering or Chemistry.5 - 8 years of experience in Quality with Pharmaceutical Manufacturing environmentKnowledge and experience applying current GMPs, ISO and regulatory standards (Health Canada, FDA).Experience with deviation investigations and complaints investigations, CAPAs identification and implementation, experience with foundational Quality System elements, including Documentation Management, Training, Change Control, Nonconformance, and Health Canada inspections.Good written and communication skills.Strong analytical skills, problem solving skills and critical thinking abilities.Risk Management knowledge (e.g., ICH Q9: Quality Risk Management).Experience applying Risk Management principles.Ability to identify interfaces between elements that should be connected (e.g., Complaints and Nonconformances).Attention to detail.Strong ability to balance multiple priorities.Knowledge of Statistical Process Control and basic statistics.Intermediate to Advanced proficiency in Word, Excel, PowerPoint.Nice to have:8 years of successful experience in a GMP pharmaceutical environment Knowledge of Six Sigma and Lean tools/ principles.Proficiency in Trackwise System.Experience with Electronic Batch Record (EBR), JDE.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to ************@baxter.com 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. 113896