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Document Control Specialist I at Forge Biologics - ApplyBlast

Document Control Specialist I

Forge Biologics

4 months ago

4.1 on Glassdoor

Columbus, Ohio

Onsite

Full Time

Junior

0 applicants

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About this role

The Document Control Specialist I at Forge Biologics ensures regulatory compliance and operates the Electronic Quality Management System within the cGMP manufacturing facility. This role involves managing document issuance, record reconciliation, and serving as an expert on systems like Veeva Vault to support gene therapy production. The position requires meticulous attention to detail and collaboration with cross-functional teams to maintain GxP standards.

Responsibilities

Issue and control documents for operations and quality departments
Reconcile GMP documentation records for accuracy and completeness
Serve as subject matter expert for Veeva Vault eQMS system
Scan and process executed batch records into the electronic system
Support regulatory inspections and internal audits with organized records

Skills

Qualifications

High school diploma or equivalentAssociate's Degree (Preferred)Bachelor's Degree (Preferred)

About Forge Biologics

forgebiologics.com

Headquarters

Columbus, Ohio, United States

Company Size

201-500 employees

Founded

2020

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Forge Biologics is a CDMO focused on accelerating gene therapy manufacturing, specializing in high‑yield adeno‑associated virus (AAV) vector production. The company offers end‑to‑end services including process and analytical development, clinical‑to‑commercial cGMP manufacturing at a world‑class facility, and regulatory and supply‑chain support. Clients partner with Forge for scalable AAV capacity, technical expertise, and seamless program support to move therapies faster toward patients.