Document Control Specialist II

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

 

Responsibilities:

• Coordinate and process internal documentation, including SOPs, Work Instructions, Forms, Batch Records, and Methods, ensuring adherence to regulatory standards.
• Act as a subject matter expert on the document management system (eQMS - Veeva Vault) to provide guidance on document authoring and revision.
• Participate in the administration of eQMS stations in manufacturing environments ensuring the availability of required procedures and reference documents.
• Evaluate and approve document change controls in the eQMS, assessing their impact on operations.
• Participate in monitoring document change requests, controlled copies, and periodic reviews in the eQMS, ensuring timely evaluation by related stakeholders.
• Issue controlled documentation and labeling, including Batch Records, to manufacturing, ensuring accuracy and compliance.
• Review completed GxP documentation, process-related forms and logbooks, for accuracy and completeness.
• Scan and process executed batch records and other GxP documentation into the eQMS efficiently.
• Assist in creating and reporting metrics and internal KPIs related to the document management system.
• Identify and implement process improvements to enhance document control and ensure compliance with internal and regulatory requirements.
• Collaborate with cross-functional teams and departments to streamline document control processes.
• Provide support during regulatory inspections and internal audits, ensuring documentation readiness and compliance

 

Qualifications:

• Associate’s Degree or High school diploma or equivalent (GED) with 2+ years relevant experience.
• Experience in a GxP environment or other regulated industry.
• Intermediate proficiency in Microsoft Office applications (Outlook, Excel, Word, 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:

• Bachelor’s Degree.
• Experience in Quality Assurance or Document Control within a GxP environment.
• Experience with eQMS, preferably Veeva Vault or another document management system.

 

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned. 

 

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

We’ve Got You Covered: 

At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

Health from day one

• Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.

Time to recharge

• A competitive paid time off plan – because rest fuels innovation.
• 12 weeks of fully paid parental leave so you can focus on family when it matters most.

Rewarding your impact

• Annual bonus opportunities for all full-time team members.
• 401(k) with company match to help you plan for the future.
• Special employee discounts, including childcare and dependent care savings.

Your wellness, supported

• Onsite fitness facility at The Hearth.
• Mental health counseling and financial planning services through our Employee Assistance Program.
• Employer-paid short and long-term disability coverage to protect your peace of mind.

Fuel for your workday

• A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.

Grow with us

• Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.