QA Operations Specialist - AAV Gene Therapy

Forge Biologics; Columbus (OH); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

12 weeks parental leave

Annual bonus opportunities

401(k) with company match

Onsite fitness facility

Employee assistance program (EAP)

Disability coverage

Job summary

Forge Biologics seeks a Specialist I, QA Operations (AAV Manufacturing) to uphold regulatory requirements and quality standards in the GMP AAV manufacturing environment. You will review batch records, assist with deviations, and maintain QA presence in manufacturing areas.

You will train personnel, support CAPA investigations, and collaborate with cross-functional teams to ensure compliant, robust processes and documentation workflows, contributing to patient-focused gene therapies.

Qualifications

• Bachelor’s Degree in a scientific or related field (or equivalent experience).
• Previous QA experience in pharma/biotech.
• Detail-oriented with multi-priority management in a fast-paced environment.
• Ability to communicate quality issues to senior management.
• Experience in GMP cleanroom manufacturing environments preferred.

Responsibilities

• Serves as a quality resource for GMP AAV manufacturing, communicating quality issues to management.
• Perform detailed review and approval of batch records and controlled documentation.
• Provide training on quality topics to manufacturing personnel.
• Support deviations and CAPA activities to prevent recurrence.
• Collaborate with Process Development, Analytical Development, and Manufacturing to support process improvements.
• Assist in documentation control: SOPs, work instructions, forms.
• Prepare for external audits and inspections related to AAV manufacturing.

Skills

Attention to detail

Cross-functional collaboration

Communication

On-call readiness

GMP knowledge

Education

Bachelor’s degree in a scientific field

Tools

eQMS (Veeva Vault)

MS Office (Excel/Word/PowerPoint)

GxP documentation systems

Job description

Forge Biologics seeks a Specialist I, QA Operations (AAV Manufacturing) to uphold regulatory requirements and quality standards in the GMP AAV manufacturing environment. You will review batch records, assist with deviations, and maintain QA presence in manufacturing areas.

You will train personnel, support CAPA investigations, and collaborate with cross-functional teams to ensure compliant, robust processes and documentation workflows, contributing to patient-focused gene therapies.