QA Operations Specialist I, AAV Manufacturing

Forge Biologics; Columbus, Northern (OH, KY); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) with company match

Onsite fitness facility

Parental leave (paid)

Annual bonus opportunities

Employee discounts

Mentorship and development programs

Free snacks and beverages

Job summary

Forge Biologics in Columbus, OH is seeking a Specialist I, QA Operations (AAV Manufacturing) to ensure regulatory compliance and uphold high quality standards in our GMP environment. You will oversee batch record review, document control, and QA support in AAV gene therapy manufacturing.

The role also involves training manufacturing staff, supporting deviations and CAPA, and partnering with Process Development, Analytical Development, and Manufacturing to drive continuous improvement.

Qualifications

• Bachelor’s Degree in a scientific or related field, or equivalent experience.
• Experience in a QA role within the pharmaceutical/biotechnology industry.
• Keen attention to detail with multiple priorities in a fast-paced environment.
• Ability to collaborate with cross-functional teams to resolve issues and ensure compliant outcomes.
• Strong communication skills to report quality issues to senior management.
• Willingness to work hours to support production and participate in an on-call rotation.
• Experience in GMP cleanroom environments with appropriate PPE.

Responsibilities

• Serve as a quality resource for GMP AAV Manufacturing, guiding management on quality issues.
• Review and approve batch records and controlled documents for AAV gene therapy manufacturing.
• Provide training on quality topics to manufacturing personnel.
• Support deviations and CAPA to prevent recurrence.
• Collaborate with Process Development, Analytical Development, and Manufacturing on process improvements.
• Maintain documentation control for SOPs and forms to ensure regulatory compliance.
• Assist in preparation for external audits and inspections.

Skills

Attention to detail

Cross-functional collaboration

Communication skills

GMP cleanroom

AAV manufacturing

Education

Bachelor's Degree in science

Tools

eQMS (Veeva)

Job description

Forge Biologics in Columbus, OH is seeking a Specialist I, QA Operations (AAV Manufacturing) to ensure regulatory compliance and uphold high quality standards in our GMP environment. You will oversee batch record review, document control, and QA support in AAV gene therapy manufacturing.

The role also involves training manufacturing staff, supporting deviations and CAPA, and partnering with Process Development, Analytical Development, and Manufacturing to drive continuous improvement.