Sr. QA Document Control Specialist

Senior Quality Assurance Document Specialist

Location: Greater Boston (Hybrid)

Overview

EPM Scientific is partnered with a clinical-stage biotechnology company to hire a Senior Quality Assurance Document Specialist. Our client is seeking a quality systems professional to support and enhance document control, training management, and quality system processes as the organization advances toward commercialization. This role offers broad exposure across Quality Operations and will play an important part in maintaining inspection readiness, supporting continuous improvement initiatives, and ensuring compliance with global regulatory requirements.

Key Responsibilities

• Administer and maintain the Document Management Program, including document creation, revision, approval, and retirement
• Manage document lifecycles within the electronic Quality Management System (eQMS)
• Review GxP documents and records to ensure compliance with internal procedures, regulatory requirements, and data integrity principles
• Serve as the primary administrator for document control activities within the eQMS
• Manage document archival and retention activities
• Administer and maintain the Training Management Program, including user roles, curricula, training assignments, and onboarding support
• Provide training and support to end users on document control and training management processes
• Support inspection readiness activities, internal audits, and quality system initiatives
• Assist with deviation, CAPA, change control, supplier qualification, and quality metrics activities
• Support eQMS improvements, validation activities, and continuous improvement initiatives

Requirements

• Bachelor's degree in a scientific or engineering discipline with 6+ years of Quality or Quality Assurance experience within biotech or pharmaceutical environments, or equivalent experience
• Experience with document control, training management, and electronic Quality Management Systems (eQMS)
• Working knowledge of GxP regulations, including 21 CFR Part 11, Annex 11, and cGMP requirements
• Familiarity with global regulatory expectations and quality systems
• Internal audit or inspection readiness experience preferred
• Strong organizational, communication, and stakeholder management skills
• Proficiency with Microsoft Office; experience with SharePoint and Smartsheet is a plus
• Ability to manage multiple priorities in a fast-paced environment
• Must be authorized to work in the U.S. without sponsorship