SPECIALIST-II, QC Chemistry

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—where your purpose accelerates our mission.

Your Role at Baxter:

Primary responsibility for ensuring the integrity of all data generated by the Baxter Alliston Chemistry Laboratory, Projects and Administration.

What you will be doing:

• Project management in support of laboratory qualifications (LE&IS), validations, method transfers, change control and other protocols.
• Review of laboratory data and ensuring the integrity of data generated by the laboratory, including LIMS review, data integrity reviews, periodic reviews (e.g. audit trails, log books, lab notebooks), GxP and computer system administration.
• Implement quality and process improvement opportunities to maximize laboratory efficiency and capacity by troubleshooting equipment issues, scheduling monthly preventative maintenance schedules, adopting test method improvements and implementing appropriate corrective and preventative measures to avoid exceptions.
• Assessment of procedural (local and corporate) and compendial requirements and revisions.
• Develop and implement equipment and testing procedures by writing and executing appropriate validation protocols in the QM lab.
• Act as LIMS administrator for Alliston facility
• Support laboratory NCR and CAPA

What do you bring:

• University Degree, Bachelor of Science
• Analytical Chemistry
• Previous experience in a GMP environment
• Experience with USP test methods
• Project management experience
• In-depth knowledge of GMP, ISO and Regulatory standards
• Preferred: • Knowledge of Corporate Quality requirements
• Practical experience using Lean tools (6S, Kaizen, Value Stream Mapping).
• Previous experience with Terminal sterilization validation
• 5+ years of experience in a chemistry lab in a pharmaceutical environment
• Strong understanding of Health Canada GMP and Medical Device Regulations.
• Previous experience writing protocols
• Ability to build relationships with internal and external customers.
• Strong ability to balance multiple priorities.
• Experience with a Laboratory Information Management System (LIMS). Analytical chemical testing lab experience in the pharmaceutical industry and knowledge of GMP, ISO standards, and regulatory/corporate requirements.
• Validation experience within a life sciences manufacturing environment.
• Experience implementing 6S; EMS in a manufacturing environment, with practical experience using Lean tools.
• Proficiency in Trackwise System

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.

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