Document Control Specialist I jobs in United States
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Glaukos Corporation · 1 month ago

Document Control Specialist I

Glaukos Corporation is seeking a Document Control Specialist to join their Quality Systems team. The role involves managing GxP document change packets and ensuring compliance with regulatory standards while supporting audits and process improvement initiatives.

Health CareMedicalWellness
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Growth Opportunities
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H1B Sponsor Likelynote

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

Qualification

Document ManagementGxP ComplianceISO13485 KnowledgeData Integrity StandardsOperational ExcellenceComputer SkillsEffective CommunicationOrganizational SkillsTeam CollaborationAttention to Detail

Required

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
Awareness of industry standards for Data Integrity and Document Control Management
Associate degree in Business Administration or related field, or equivalent education and experience

Preferred

Experience in pharmaceuticals and knowledge of ISO13485, 21CFR820, and 21CFR210/211
Operational excellence experience
Bachelor's degree in a science discipline

Company

Glaukos Corporation

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At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases—therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.

H1B Sponsorship

Glaukos Corporation has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (1)
2022 (3)
2021 (1)

Funding

Current Stage
Public Company
Total Funding
$121M
Key Investors
Meritech Capital PartnersOrbiMed
2015-06-25IPO
2013-02-07Series F· $30M
2012-10-03Debt Financing· $6M

Leadership Team

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Alex Thurman
Senior Vice President and Chief Financial Officer
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Joseph Gilliam
President & Chief Operating Officer
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Company data provided by crunchbase