Job Summary

The QA Documentation Specialist I will support the Quality Assurance team by managing documentation in compliance with GMP standards. This role ensures accuracy, completeness, and proper control of records and documentation while contributing to continuous improvement of quality systems.

Key Responsibilities

• Maintain continuous development and knowledge of GMP regulations.
• Support implementation and continuous improvement of Quality Systems.
• Manage record control, including receipt, reconciliation, scanning, verification, check-out/check-in, and maintaining scanned record backups.
• Handle controlled document issuance, numbering, and tracking.
• Support internal and external audit activities.
• Perform other duties as assigned by the Quality Assurance department.

Qualifications & Skills

• Attention to detail with strong organizational and documentation skills.
• Excellent oral and written communication abilities.
• Proficiency in Microsoft Word and Excel.
• Self-motivated, positive attitude, and capable of working effectively with cross-functional teams in a fast-paced environment.