Document Control Specialist II

Forge Biologics • Columbus, OH

11h • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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

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 – 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 101-250 employees