Document control Lead Regulatory

Job Overview

Responsible for managing and maintaining the document control system to ensure compliance with GMP regulations, which includes reviewing, organizing, and archiving controlled documents (SOPs, change control, specifications, etc.). The role involves tracking document revisions, ensuring timely distribution of updated materials, and supporting audits by providing accurate documentation.

The coordinator collaborates with cross-functional teams—including quality assurance, production, and regulatory affairs—to uphold documentation integrity and facilitate continuous improvement in quality systems. Reports to the Regulatory Manager.

Responsibilities

• Responsible for the administration of the Mason Vitamins controlled document system. (Standard Operating Procedures, Official Forms, Quality Manual, Master Batch Records, Master Packaging Records, Specifications, analytical methods, etc.)
• Performs Quality Assurance reviews of completed batch documentation for completion, accuracy, use of proper documentation practices
• Tracks and reports Quality System Metrics in support of Quality Systems Reporting to management.
• Archives Quality Agreements, specifications, customer information documents, and standards
• Responsible for responses to Customer Service/Marketing Documentation Requests.
• Develops and/or updates relevant SOPs.
• Responsible for the participation in internal plant audits, dissemination of audit reports, tracking of responses, and documenting closure of audit items. Responsible for ongoing reporting of audit status for Quality Systems Reporting.
• Responsible for coordinating and filing Quality Assurance training activities,s including individual training logs.
• Assists with and documents Regulatory inspections and Customer audits.
• Functions as a technical advisor and problem solver for quality personnel.
• Accountable for the completion and timeliness of appropriate reporting and coordination of quality system activities
• If you are passionate about maintaining high-quality documentation standards and thrive in an organized environment, we encourage you to apply for this exciting opportunity as a Document Control Clerk.

Job Type: Full-time

Pay: $48,000.00 per year

Experience

• Microsoft Office: 1 year (Preferred)

Work Location: In person