Document Control Specialist I

Glaukos Corporation • Burlington, MA

5d

About The Position

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.

Requirements

• 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.
• Associate degree in Business Administration or related field, or equivalent education and experience.

Nice To Haves

• 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.
• Bachelor’s degree in a science discipline preferred.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees