Quality Documentation Specialist 2 - Remote

Overview

The Quality Documentation Specialist 2 is responsible for monitoring change statuses, managing documentation processes, and ensuring compliance with FDA and GMP standards in a telecommute role.

In Short

• Monitor change status and chair meetings with Corporate.
• Manage system library and provide solutions to change issues.
• Train users on Change Control processes.
• Process Change Control Notifications in Windchill and GPDM systems.
• Maintain updated documentation databases.
• Implement and maintain standard operating procedures.
• Support Sr. Documentation Systems Manager with various functions.
• Ensure compliance with regulations and SOPs.
• Write and implement changes to documents.
• Respond to internal audit observations and corrective actions.

Requirements

• Bachelor’s degree.
• Minimum 1 year of experience in a similar position.
• Bilingual in English and Spanish.
• Excellent oral and written communication skills.
• Proficient in Windchill, GPDM, MS Office, MS VISIO, AutoCAD, and SolidWorks.
• Good data entry skills.
• Knowledge of FDA and GMP standards.

Benefits

• Opportunity to work in a top workplace environment.
• Commitment to sustainability and employee recognition programs.
• Collaborative culture and core values.