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Forge Biologics is seeking a QA Operations Specialist I to join their Quality Assurance team supporting AAV gene therapy manufacturing at their state-of-the-art 200,000-square-foot cGMP facility in Columbus, Ohio. This role is central to ensuring compliance with regulatory requirements and maintaining the highest quality standards in a cutting-edge biotech manufacturing environment.
The Specialist I will serve as a quality resource embedded in the GMP AAV Manufacturing department, working directly in and overseeing operations within the cleanroom manufacturing environment. Key responsibilities include providing guidance to manufacturing teams, communicating quality issues to management, and maintaining a consistent QA presence throughout production activities.
Core duties encompass detailed review and approval of batch records and associated documentation for AAV gene therapy manufacturing, including logbooks and controlled documentation. The role supports document control processes, batch record review, and helps maintain regulatory compliance across all manufacturing operations.
This is an individual contributor role focused on quality oversight, compliance, and operational excellence in a highly regulated biotech setting. The ideal candidate will have a strong understanding of GMP principles, cGMP manufacturing environments, and gene therapy production processes. You'll work collaboratively with manufacturing teams to identify and resolve quality issues, ensure proper documentation, and support the company's mission of bringing life-changing gene therapies to patients.
Forge Biologics operates with a culture centered on H.O.P.E.: hardworking, open, purpose-driven, and engaged. The company is committed to employee growth through mentorship, hands-on learning, and career development opportunities.
