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'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 Quality Analyst plays a key role in supporting the External Contract Manufacturing Quality organization.What you'll be doing• Review and approve manufacturing records (batch and DHR records) for products manufactured by External Contract Manufacturing suppliers Organizations to ensure accuracy and completeness. This may include a review of Minor nonconformance reports related to the manufacture of these products.• Generate Baxter Certificates of Conformance and Certificates of Analysis (CoC/CoA) for these products when required.• Utilize electronic systems (e.g., JDE, Bot, SharePoint) for creating and storing quality records.• Utilize electronic systems (e.g., Trackwise) for maintaining supplier quality records and uploading requirements.• Assist with periodic supplier requirement reviews by confirming and/or obtaining quality requirements such as quality agreements, surveys, or quality certificates.• Assist with supplier-related change control tasks as assigned/required.• Assist with External Contract Manufacturing Quality controlled document revisions as needed.• Assist with automated Bot performance monitoring (and associated IT validation activities as required).• Assist with external supplier access requests to Baxter Certificate Repository.• Assist with Baxter and supplier batch record retention/archival as needed.• Assist with external product complaint sample shipment coordination.• Participate in continuous improvement activities and projects (i.e., CAPA, Product Improvement teams). May lead projects assigned by management.• Interpret and execute policies and procedures that affect the organizational unit.• Interact frequently with functional peer groups, area management, and Baxter's suppliers.• Manage workflow: identify and escalate issues as needed.• Other duties, task, or projects as assigned/required.What you'll bring:• Knowledge of GMP, documentation and Data Integrity requirements.• Knowledge of Quality Management System requirements (e.g., ISO 9001, ISO 13485, etc.).• Knowledge of Medical Device and Drug/Biologic product regulation requirements (21 CFR Parts 4, 11, 600, 820, 210/211, EU MDR, etc.).• Bachelor's degree in science, engineering, or another technical area.• 1 year of experience working in the pharmaceutical, medical device, or biotech industry preferred.• Fluent in English• Familiarity with regulatory (e.g., U.S. FDA) and ISO 13485 requirements preferred.#LI-GR1
