Specialist-I (BaxLIMS Support)

2 weeks ago

Alliston, Ontario, Canada Baxter Full time

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

In this role, you will be primarily responsible for ensuring the integrity of all data generated by the Baxter Alliston Chemistry Laboratory, Projects and Administration.

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 6s

Quality : 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 procedures completing training on-time Doing it Right the First Time, and reporting 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 activities identifying and implementing continuous improvement ideas participating in Tier meetings recognizing your peers, and embracing 6s. identifying and implementing VIP's (Value Improvement Project) embrace continuous learning utilize Leader Standard Work utilize Root Cause Analysis tools to identify and prevent problems from recurring and drive measurable results.

What you'll 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 you'll have:

University Degree, Bachelor of Science or equivalent 2 – 3 years experience Analytical Chemistry or Computer Science Previous experience in a GMP environment Experience with USP test methods Project management experience In-depth knowledge of GMP, ISO and Regulatory standards 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. Previous experience writing protocols Ability to build relationships with internal and external customers. Strong ability to balance multiple priorities. Intermediate level MS Office (Excel, Word, PowerPoint). 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.

Nice to have:

Masters Degree 5+ years of successful experience Knowledge of Corporate Quality requirements Practical experience using Lean tools (6S, Kaizen, Value Stream Mapping). Previous experience with Terminal sterilization validation 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

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