Quality Document Management Specialist I

Advarra • United States of America,

2d • $64,344 - $106,168 • Remote

About The Position

The Document Management Specialist I supports the Quality Assurance/Compliance Department by administering and maintaining controlled documentation within Advarra’s Quality Management System (QMS). This role ensures documentation integrity, regulatory compliance, and inspection readiness by supporting document lifecycle management, audit activities, and quality system processes. The role collaborates within QA/Compliance and across the organization to support effective quality and training systems.

Requirements

• Bachelor’s degree or equivalent experience
• 2–4 years of relevant experience in document control, quality systems, or regulated operations.
• Excellent organizational skills, managing priorities, deadlines, and workload.
• Demonstrate attention to detail, accuracy, and thoroughness.
• Effectively and professionally communicate with all levels of staff.
• Proficiency with Microsoft Office tools (Word, Excel, SharePoint/OneDrive).
• Ability to identify and resolve problems.
• Ability to work independently; effectively balance team and individual responsibilities.

Nice To Haves

• Experience managing controlled documents, especially within a Quality Management System (QMS) in an FDA (or similar) regulated business.
• Experience, training, or certifications in Quality Assurance.
• Knowledge of Federal regulations for human research (21 CFR 50, 56, 312 and 812; and 45 CFR 46)
• Experience with electronic Quality Management Systems (eQMS) or EDMS platforms (e.g., ZenQMS, Veeva, MasterControl, or SharePoint-based systems).
• Familiarity with GxP, ISO 9001, or ISO 13485 quality systems

Responsibilities

• Management of controlled documents (policies, procedures, work instructions, reports, and records) within the QMS. Maintain documents throughout their lifecycle, including creation, review, approval, revision, version control, archival, and retirement. Ensure documentation complies with Good Documentation Practices (GDocP).
• Maintenance of user accounts, roles, permissions, workflows, document categories, review cycles, and retention rules within the Electronic Document Management System (EDMS).
• Assist with retrieval of controlled documents in support of customer audits, inspections, and assessments. Support tracking and coordination of customer assessment requests.
• Communicate training and document review requirements to quality system users. Support the Training and Compliance teams to ensure alignment between the EDMS and the training matrix.
• Administration of nonconformance reports (Quality Incident Reports (QIRs) and CAPAs). Identify issues, recommend process improvements, and contribute to quality system enhancements.
• Make decisions within established guidelines and procedures.
• Perform other duties as assigned.

Benefits

• health coverage
• paid holidays
• variable bonus
• other benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree