What are the responsibilities and job description for the Document Control Specialist I position at Glaukos Corporation?
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.
#GKOSUS
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.
#GKOSUS