QA Operations Specialist I, AAV Manufacturing

Forge Biologics; Columbus (OH); On-site; USD 75,000 - 105,000; Full time

Job summary

Forge Biologics is seeking a Specialist I, QA Operations (AAV Manufacturing) to ensure regulatory compliance and uphold high quality standards in our GMP cleanroom environment. You will support document control, batch record reviews, and maintain a QA presence across AAV gene therapy manufacturing areas.

The role requires collaboration with Process Development, Analytical Development, and Manufacturing teams, along with deviations and CAPA activities, audits, and continual process improvements.

Qualifications

• Bachelor’s degree in a scientific or related field (or equivalent experience).
• Experience in a quality assurance role within pharma/biotech.
• Keen attention to detail with accurate documentation across tasks.
• Ability to collaborate with cross-functional technical groups to resolve issues.
• Strong communication skills to convey quality issues to leadership.
• Willingness to work production hours and participate in on-call rotation.
• Ability to work in a GMP cleanroom environment with appropriate PPE.

Responsibilities

• Serve as a quality resource for GMP AAV manufacturing, guiding management on quality issues in the cleanroom.

Skills

Attention to detail

Cross-functional collaboration

Quality issues communication

GMP compliance

Documentation accuracy

On-call readiness

Cleanroom operations

Education

Bachelor’s degree in science or related field

Tools

eQMS (Veeva Vault)

Microsoft Office (Outlook/Teams/Word/Excel/PowerPoint)

Job description

Forge Biologics is seeking a Specialist I, QA Operations (AAV Manufacturing) to ensure regulatory compliance and uphold high quality standards in our GMP cleanroom environment. You will support document control, batch record reviews, and maintain a QA presence across AAV gene therapy manufacturing areas.

The role requires collaboration with Process Development, Analytical Development, and Manufacturing teams, along with deviations and CAPA activities, audits, and continual process improvements.