Job Description

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\xe2\x80\x94where your purpose accelerates our mission. SUMMARY OF RESPONSIBILITIES

• Responsible for coordinating with the Microbiology Manager and Supervisors to ensure compliance to required timelines for the completion of all Microbiology NCRs, CAPAs, OOLs and training.
• Schedules, coordinates and performs investigations associated with Microbiology data non-conformances with all involved Microbiologists.
• Determines through observations, in-depth employee interviewing and flow charting, the issues and elements of the process or system which potentially prevent an individual from performing a function correctly or act as a deterrent to the proper performance of the function.
• Monitors Microbiologists training status to maintain compliance to the training curriculum.
• Monitors the status of review for the lab to ensure that all records are complete and up to date.
• Tracks batch release dates to ensure that the lab is on target to meet dates.
• Performs document changes for the laboratory.
• Supports completion of CAPA tasks.
• Tracks all CAPAs to closure ensuring timeliness of all actions including correction/containment, investigation, corrective/preventive actions/effectiveness and closure.
• Reviews Corporate Quality Procedures and policies and new/revised Health Canada guidance documents/regulations to ensure local procedures are maintained appropriately.
• Performs instructor led training with the Microbiologists.
• Creates trending reports for product results and environmental monitoring.

Major Responsibilities / Activities

• Schedules, coordinates and performs investigations associated with Microbiology data non-conformances with all involved Microbiologists.
• Coordinates with the Microbiology Manager and Supervisors to ensure compliance to required timelines for the completion of all Microbiology NCRs, CAPAs, OOLs and training.
• Performs document changes for the Microbiology laboratory.
• Supports completion of CAPA tasks.
• Tracks all CAPAs to closure ensuring timeliness of all actions including correction/containment, investigation, corrective/preventive actions/effectiveness and closure.
• Oversees the NCR/CAPA process for the lab, ensuring that records are initiated and addressed in a timely fashion in accordance with Quality Management System (QMS) Requirements.
• Monitors Microbiologists training status to maintain compliance to the training curriculum and timelines.
• Performs instructor led training with the Microbiologists.
• Monitors the status of review for the lab to ensure that all records are complete and up to date.
• Tracks batch release dates to ensure that the lab is on target to meet dates.
• Reviews Corporate Quality Procedures and policies and new/revised Health Canada guidance documents/regulations to ensure local procedures are maintained appropriately.University Degree, Bachelor of Science

JOB REQUIREMENTS

• University Degree, Bachelor of Science
• Experience in writing OOL and/or non-conformance investigations
• Manufacturing & Quality background
• Previous experience in a GMP environment
• Knowledge of GMP, ISO and Regulatory standards
• 2 \xe2\x80\x93 3 years experience in a pharmaceutical environment
• Strong understanding of Health Canada GMP and Medical Device Regulations.
• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Strong process and project management capabilities.
• Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
• Ability to build strong relationships with internal and external customers.
• Strong ability to balance multiple priorities.
• Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action.
• Strong analytical and problem solving skills and critical thinking abilities.
• Intermediate to Advanced proficiency in Word, Excel, Powerpoint.
• Must interpret regulations and standards based on good quality practices and good business requirements.
• Must be able to build good relationships with internal and external customers.
• Maintain technical expertise and method/procedure knowledge to support good decision making.
• Maintain quality and patient safety first while recognizing the importance of good business decisions.

Reasonable Accommodations Baxter 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 Americas_TTA@baxter.com 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. 090454