Document Management Specialist

Overview

• Join a dynamic team as a Document Management Specialist on a part-time, remote basis.
• Maintain the integrity and compliance of quality and regulatory documentation.
• Support audits, inspections, and product lifecycle activities effectively.
• Ensure controlled documents meet internal standards and regulatory requirements.
• Collaborate with cross-functional teams to manage document workflows.
• Enhance efficiency and compliance through system performance monitoring.
• Contribute to the creation and standardization of SOPs and work instructions.
• Oversee document retention schedules and secure destruction of obsolete records.

Key Responsibilities & Duties

• Administer and maintain the electronic Document Management System (eDMS).
• Ensure compliance with FDA 21 CFR Part 11, ISO 13485, and other regulations.
• Support audits by retrieving and organizing documentation efficiently.
• Collaborate with teams to manage document workflows and approvals.
• Monitor system performance and recommend improvements.
• Assist in formatting and standardizing SOPs and forms.
• Maintain document retention schedules and oversee secure destruction.
• Ensure accurate version control and user access within eDMS.

Job Requirements

• Bachelor’s degree in Life Sciences, Information Management, or related field.
• Minimum of 3 years of experience in document control within a regulated industry.
• Proficiency with electronic document management systems such as MasterControl or SharePoint.
• Strong understanding of regulatory standards like FDA, ISO, and EU MDR.
• Exceptional attention to detail and organizational skills.
• Ability to manage multiple priorities and meet deadlines effectively.
• Preferred experience with product submissions or clinical trial documentation.
• Familiarity with change control and CAPA processes is advantageous.