Senior QA Document Control & Training Lead

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

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.