Document Control Specialist

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.

• 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.

• 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.

• 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. Regularly operate a computer and other office equipment.

Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs.

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.

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

• 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.

• 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.

• 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.

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

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