<p>Document Control Specialist (Burlington, MA)</p> <p>Position Overview</p> <p>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.</p> <p>Key Responsibilities</p> <ul> <li>Administer electronic and physical record documentation processes and systems. </li><li>Serve as a subject matter expert for document management and change processes. </li><li>Review documentation for compliance and coordinate with relevant departments. </li><li>Oversee creation, revision, and release of SOPs, policies, work instructions, drawings, protocols, reports, and other GxP documents. </li><li>Develop and manage tools for tracking document management metrics. </li><li>Create and maintain templates and procedures for documentation efficiency and compliance. </li><li>Train new users on the electronic Document Management System. </li><li>Monitor and execute systematic document reviews. </li><li>Lead or support department improvement projects, including system testing and integration. </li><li>Mentor junior team members and provide backup support for document distribution and archiving. </li><li>Participate in regulatory and certification audits as needed. </li><li>Support company initiatives related to Quality Management Systems, Environmental Management Systems, and regulatory requirements. </li><li>Ensure compliance with FDA, EUMDR, and other regulatory standards. </li><li>Foster positive collaboration across all levels of the organization. </li></ul> <p>Qualifications</p> <ul> <li>0-2 years of experience with a bachelor's degree, or 4+ years with an associate degree. </li><li>Strong computer skills (spreadsheets, word processing, presentations, databases). </li><li>Excellent organizational, follow-up, and attention to detail. </li><li>Effective communication skills at all organizational levels. </li><li>Ability to work independently and as part of a team in a fast-paced environment. </li><li>Experience in pharmaceuticals and knowledge of ISO13485, 21CFR820, and 21CFR210/211 preferred. </li><li>Awareness of industry standards for Data Integrity and Document Control Management. </li><li>Operational excellence experience preferred. </li></ul> <p>Education</p> <ul> <li>Associate degree in Business Administration or related field, or equivalent education and experience. Bachelor's degree in a science discipline preferred. </li></ul> <p>#GKOSUS</p>