Document Control Specialist I

Forge Biologics • Columbus, OH

14h • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• 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
• 12 weeks of fully paid parental leave
• Annual bonus opportunities for all full-time team members.
• 401(k) with company match
• 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
• A fully stocked kitchen with free snacks and beverages
• Ongoing professional development resources, training, and mentorship programs

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED