Stability Coordinator
Found in: Talent CA C2 - 2 weeks ago
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:
The Stability Coordinator supports new and established product stability studies through scheduling, monitoring and direct interaction with Chemistry and Sterility Assurance staff. There may be interaction with global teams in this role. This role is responsible for the success of the stability program at the site.
What you'll be doing:
Create stability protocols, pull stability samples according to pre-established schedules, monitor completion of testing. Manage the annual long-term stability requirements by preparing an annual list of product requirements.
Participate in laboratory investigations as investigator when there are potential out of limit results obtained for stability tests. Update documents (e.g., SOPs, forms, etc) Collate stability data and perform stability trending in support of existing stability studies.
Provide or support stability assessments and requirements for new product or product changes, including developing technical justifications in support of expiration dating for new or modified products.
Provide technical consultation to manufacturing and research personnel.
What you'll be having:
University Degree, B.Sc or equivalent designation
2 - 3 years of experience in a manufacturing facility, preferably in a Stability function
Experience in a manufacturing environment
Proficiency in Word & Excel
Previous experience with Laboratory Information Management System (LIMS)
Previous experience working in a Quality function
Previous experience working with ICH Stability requirements
Knowledge of GMP, GLP, GDP, Health Canada and FDA guidelines
Ability to work independently and as part of a team, self-motivated, adaptable, with a positive attitude.
Ability to make routine decisions independently
Must be available to work a schedule outside business hours and/or flexible shifts.
Intermediate level of proficiency with MS Office and Laboratory information management system (LIMS)
Strong ability to balance multiple priorities with excellent time management skills.
Detail oriented with the ability to work under pressure.
Uncompromising dedication to quality.
Strong verbal and written communication skills
Nice to have:
5+ years of successful progressively responsible experience working in Quality and Stability
Understanding of EMS through the application of LEAN tools in a laboratory environment
Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, etc.
Strong technical writing skills.
Strong analytical and problem solving skills and critical thinking abilities
#LI-BAXGEN
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