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Specialist I, QA Operations

Forge Biologics · Columbus, Ohio · On-site

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About Forge Biologics

Forge Biologics is a gene therapy development engine, focused on enabling access to life-changing gene therapies and helping bring them from an idea into reality. Backed by Drive Capital.

About the role

We are currently seeking a Specialist I, QA Operations (AAV Manufacturing) to join the Forge Biologics Team. The Specialist I, QA Operations is responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards. Th is role will support the Quality Assurance team in activities such as document control, batch record review, and helping maintain a QA presence in AAV gene therapy manufacturing areas.

What they're looking for

  • Bachelor’s Degree in a scientific or related field (or equivalent experience)
  • Previous experience in a quality assurance role within the pharmaceutical or biotechnology industry
  • Proven track record of keen attention to detail, consistently ensuring accuracy and precision in all tasks and documentation, managing multiple priorities in a fast-paced environment
  • Ability to collaborate with cross-functional technical groups to resolve issues, close gaps, and ensure compliant outcomes which are efficient and robust
  • Strong communication skills, including the ability to effectively communicate quality issues to senior management
  • Ability to work the hours necessary to support production and participate in an on-call rotation providing off-hours support for AAV manufacturing needs and issues
More about this role

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking , showing up each day with determination and grit. We are open , creating a space where ideas flow freely, and every voice is valued. We are purpose-driven , with every task directly tied to changing lives. And we are engaged , energized by the challenges we face and the milestones we achieve...

Read the full posting on Forge Biologics's site ↗

Quality Management

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