Analyst, Quality Documentation

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.

Summary
Responsible for supporting the QMS and managing the development and revision of standard procedures and training materials for a global audience. Participate and drive department assessments and assure closure to items identified. Support and lead department improvement projects through successful implementation. Must have the ability to manage projects, work in a team setting and encourage teamwork and drive decisions. Provide guidance to internal/external customers on document and system related issues. Review and approve GMP/GLP Manufacturing and related documentation to support timely product and system release.
Essential Duties and Responsibilities.

The incumbent will perform other duties as assigned.
1) Highly proficient in project and configuration management.
2) Strong technical writing skills for creating and editing content, particularly to procedures and templates that support the global Quality Management System.
3) Leading document creation and initiation activities while maintaining effective communication and developing partnerships with customers globally. 4) Provide training to internal and external personnel on documentation/labeling/archive related processes and systems. 5) Perform/assist in internal assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Maintain expertise in quality systems and quality techniques.
6) Actively participate in process improvement and the implementation of new/enhanced processes. 7) Maintain a high level of expertise in current regulatory requirements and technical issues. Participate in QA/QC multi-site projects in the role of contributor, coordinator or leader.
8) Support internal and external audit activities.

Qualifications.

• Proficient in the document change control process.
• Skilled in Desktop publishing, Graphics/Illustrations software and document management (e.g. Word) software applications.
• Data/Document configuration management proficiency.
• Facilitating training.
• Strong project management skills.
• Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
• Familiarity with interpreting regulations and quality systems.
• Understand strategies and be able to develop new businesses process/tools.
• Good interpersonal/communication/influencing/negation skills.
• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Knowledge of product/document configuration management.
• Working knowledge of related business systems.
• Working knowledge Quality Management Systems

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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