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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.