Specialist I, QA Operations (2nd Shift)

The role

The Specialist I, QA Operations supports the Quality Assurance team with document control, batch record review, and maintaining a QA presence in AAV gene therapy manufacturing areas. This role ensures compliance with regulatory requirements and maintains quality standards.

What you will do

• Serves as a quality resource for the GMP AAV Manufacturing department in the cleanroom environment
• Communicates quality issues to management
• Performs detailed review and approval of batch records, logbooks, and controlled documentation
• Provides training and guidance to manufacturing personnel on quality topics
• Supports deviations and continuous improvements through root cause analysis and CAPA
• Collaborates with cross-functional teams to support process improvement
• Supports the documentation control process including reviewing and revising SOPs, work instructions, and forms
• Assists in the preparation for external audits and inspections

Required qualifications

• 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
• Ability to collaborate with cross-functional technical groups
• Strong communication skills
• Ability to work the hours necessary to support production and participate in an on-call rotation
• Ability to work in a GMP cleanroom environment wearing required PPE

Nice to have

• Direct experience in providing QA support for cGMP manufacturing operations in a cleanroom environment
• Experience working in the production of biologics (ex. gene therapies)
• Knowledge of cGMP regulations, quality systems, and quality assurance principles
• Experience utilizing an eQMS, preferably Veeva Vault or another document management system
• Intermediate proficiency in Microsoft Office applications (Outlook, Teams, Word, Excel, and PowerPoint)
• Experience supporting internal audits and participating in external audits or inspections

Benefits

• Health, dental and vision insurance start your first day with 90% of premiums covered for you and your family
• Competitive paid time off plan
• 12 weeks of fully paid parental leave
• Annual bonus opportunities
• 401(k) with company match
• Special employee discounts, including childcare and dependent care savings
• Onsite fitness facility at The Hearth
• Mental health counseling and financial planning services through Employee Assistance Program
• Employer-paid short and long-term disability coverage
• Fully stocked kitchen with free snacks and beverages
• Ongoing professional development resources, training, and mentorship programs

About the company

Forge Biologics aims to enable access to life-changing gene therapies. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.