Quality Assurance Operations Specialist I, AAV Manufacturing, 2nd Shift

Job overview

The Quality Assurance Operations Specialist I, AAV Manufacturing, 2nd Shift role is an onsite position in Columbus, OH; compensation is not specified. Forge Biologics works to enable access to life-changing gene therapies at its Columbus cGMP facility. This role supports compliant AAV gene therapy manufacturing by providing quality oversight, reviewing batch records and controlled documents, and helping manufacturing teams meet regulatory and quality standards.

What you'll do

• Oversee GMP AAV manufacturing operations in the cleanroom as a quality resource
• communicate quality issues to management
• review and approve batch records, logbooks, and controlled documentation
• train manufacturing personnel on quality topics
• support deviations, root cause analysis, CAPA, and continuous improvement
• review and revise SOPs, work instructions, and forms
• assist with external audits and inspections.

What we're looking for

Skills & competencies

quality assurance

aav manufacturing

gene therapy

gmp

cgmp

batch records

document control

cleanroom

columbus oh

forge biologics

on-call rotation

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, dental, and vision insurance from day one with 90% of premiums covered for employee and family
• paid time off
• 12 weeks paid parental leave
• annual bonus opportunities
• 401(k) match
• employee discounts
• onsite fitness facility
• Employee Assistance Program
• employer-paid short- and long-term disability
• free snacks and beverages
• professional development, training, and mentorship.

Why this role

Supports AAV gene therapy manufacturing; requires participation in an on-call rotation for off-hours manufacturing support.

About the employer

Forge Biologics is hiring for this role. Industry: Offices of Physicians (except Mental Health Specialists). Sector: 62.