Document Control Specialist I

Document Control Specialist (Burlington, MA)

Position Overview

Join the Quality Systems team as a Document Control Specialist, responsible for managing GxP document change packets using electronic systems in compliance with Glaukos's Quality Management System and regulatory standards. This role involves independent decision-making, process improvement, mentoring team members, and supporting audits.

Key Responsibilities

• Administer electronic and physical record documentation processes and systems.
• Serve as a subject matter expert for document management and change processes.
• Review documentation for compliance and coordinate with relevant departments.
• Oversee creation, revision, and release of SOPs, policies, work instructions, drawings, protocols, reports, and other GxP documents.
• Develop and manage tools for tracking document management metrics.
• Create and maintain templates and procedures for documentation efficiency and compliance.
• Train new users on the electronic Document Management System.
• Monitor and execute systematic document reviews.
• Lead or support department improvement projects, including system testing and integration.
• Mentor junior team members and provide backup support for document distribution and archiving.
• Participate in regulatory and certification audits as needed.
• Support company initiatives related to Quality Management Systems, Environmental Management Systems, and regulatory requirements.
• Ensure compliance with FDA, EUMDR, and other regulatory standards.
• Foster positive collaboration across all levels of the organization.

Qualifications

• 0-2 years of experience with a bachelor's degree, or 4+ years with an associate degree.
• Strong computer skills (spreadsheets, word processing, presentations, databases).
• Excellent organizational, follow-up, and attention to detail.
• Effective communication skills at all organizational levels.
• Ability to work independently and as part of a team in a fast-paced environment.
• Experience in pharmaceuticals and knowledge of ISO13485, 21CFR820, and 21CFR210/211 preferred.
• Awareness of industry standards for Data Integrity and Document Control Management.
• Operational excellence experience preferred.

Education

• Associate degree in Business Administration or related field, or equivalent education and experience. Bachelor's degree in a science discipline preferred.

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