Document controller

Quality Control/Quality Analyst – Document Controller / Regulatory Compliance Officer

Qualifications

• Graduate of BS Chemistry or Chemical Technician
• Preferably with experience in Quality Control or Document Control
• Knowledge and exposure in FDA processes, particularly LTO, CPR, and CPN applications
• Familiar with GMP, quality documentation systems, and regulatory procedures
• Detail-oriented, organized, and able to manage multiple documentation tasks

Key Responsibilities

• Maintain and organize all quality-related documents, including SOPs, test results, and certifications
• Assist in the preparation, submission, and monitoring of FDA requirements such as LTO, CPR, CPN
• Support internal quality audits and ensure compliance with GMP and regulatory guidelines
• Coordinate with internal departments for document routing and control