Sr. QA Document Control Specialist

EPM Scientific; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

EPM Scientific is partnering with a clinical-stage biotechnology company to hire a Senior Quality Assurance Document Specialist. The role focuses on document control, training management, and quality system processes to support readiness for commercialization.

Responsibilities include maintaining the Document Management Program, overseeing the eQMS, training management, audits, deviations, CAPA, and quality metrics while ensuring compliance with global regulations and data integrity.

Qualifications

• Bachelor's degree in a scientific or engineering discipline and 6+ years in quality within biotech/pharma.
• Experience with document control, training management, and eQMS.
• Knowledge of 21 CFR Part 11, Annex 11, and cGMP requirements.
• Internal audit or inspection readiness experience preferred.

Responsibilities

• Administer and maintain the Document Management Program across the eQMS.
• Manage document lifecycles, revisions, approvals, and retirement.
• Review GxP documents to ensure regulatory compliance and data integrity.
• Serve as primary administrator for document control within the eQMS.
• Oversee Training Management Program and onboarding support.
• Support inspection readiness, internal audits, and quality metrics.
• Assist with deviation, CAPA, change control, and supplier qualification.

Skills

Document control

eQMS

GxP knowledge

Regulatory compliance

Internal audits

Stakeholder management

Education

Bachelor's degree in science or engineering

Tools

Microsoft Office

SharePoint

Smartsheet

Job description

Senior Quality Assurance Document Specialist

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? ? A?"> ?"