Analyst, Quality Documentation, Baxter

Analyst, Quality Documentation

Baxter

Location:

Mexico, Tijuana

Category:

Quality Control

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

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 ensure closure to items identified. Support and lead department improvement projects through successful implementation. 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.

Job Responsibility:

Highly proficient in project and configuration management
strong technical writing skills for creating and editing content, particularly to procedures and templates that support the global Quality Management System
leading document creation and initiation activities while maintaining effective communication and developing partnerships with customers globally
provide training to internal and external personnel on documentation/labeling/archive related processes and systems
perform/assist in internal assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude
actively participate in process improvement and the implementation of new/enhanced processes
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
support internal and external audit activities.

Requirements:

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 business processes/tools
good interpersonal/communication/influencing/negotiation 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 of Quality Management Systems.

What we offer:

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer.

Additional Information:

Job Posted:

March 20, 2025

Work Type:

On-site work

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