Document Control Specialist

Position: Document Control Specialist I
Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen - you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us.

If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself.

About The Role:

The Document Control Specialist I, Quality Assurance plays a pivotal role in ensuring regulatory compliance and seamless operation of the document management system utilizing an Electronic Quality Management System. This position is responsible for overseeing Document Control and Records Management functions, with a focus on maintaining GxP standards.

Responsibilities:

• Issue controlled documents, including batch records, labeling, forms, and logbooks, to Operations and Quality Control departments, ensuring they are accurate, complete, and compliant.

• Collaborate with cross-functional teams to streamline document issuance and reconciliation processes across departments.

• Reconcile and review completed GMP documentation records for accuracy and completeness.

• Serve as a subject matter expert for the document management system (eQMS/Veeva Vault) and provide guidance on document authoring and revision.

• Scan and process executed batch records and other GMP documentation into the eQMS in a timely and efficient manner.

• Support the creation and reporting of metrics and internal KPIs related to the document management system.

• Identify and implement process improvements that strengthen document control and support compliance with internal and regulatory requirements.

• Support regulatory inspections and internal audits by ensuring documentation is organized, complete, and inspection-ready.

Qualifications:

• High school diploma or equivalent (GED).

• Intermediate proficiency in Microsoft Office applications (Outlook, Teams, Word, Excel, and Powerpoint).

• Proven track record of keen attention to detail, consistently ensuring accuracy and precision in all tasks and documentation.

• Strong communication skills, both written and verbal.

Preferred Skills:

• Associate's or Bachelor's Degree.

• Basic proficiency with Project Management software (Smartsheet).

• Advanced proficiency with Microsoft Office applications (Outlook, Teams, Word, Excel, and Powerpoint).

• Experience in Document Control, Records Management, or Quality Assurance within a GMP environment.

• Experience with eQMS, preferably Veeva Vault or another document management system.

This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment.…