Specialist I, QA Operations

Drive Capital; Columbus (OH); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Parental leave

401(k) with company match

Employee discounts

Job summary

Forge Biologics seeks a Specialist I, QA Operations to ensure regulatory compliance and uphold high quality in AAV manufacturing. You will support document control, batch record reviews, and maintain QA presence on the manufacturing floor.

Role requires collaboration with cross‑functional teams, training on quality topics, and CAPA support. On‑call rotation and GMP environment experience preferred in Columbus, OH.

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 and ability to manage multiple priorities.

Responsibilities

• Serves as a quality resource for GMP AAV manufacturing, guiding management on quality issues arising in manufacturing.
• Review and approve batch records and associated documentation to ensure adherence to procedures and cGMP regulations.
• Provide training and guidance to manufacturing personnel on quality topics and regulatory requirements.
• Support deviations and CAPA activities related to AAV manufacturing processes and assist with root cause analysis.
• Collaborate with cross-functional teams to support continuous process improvement and alignment with quality objectives.
• Maintain documentation control, review SOPs, work instructions, and forms for compliance.
• Assist in preparations for external audits and inspections for regulatory or client audits.

Job description

About The Role:

We are currently seeking a Specialist I, QA Operations (AAV Manufacturing) to join the Forge Biologics Team. The Specialist I, QA Operations is responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards. Th is role will support the Quality Assurance team in activities such as document control, batch record review, and helping maintain a QA presence in AAV gene therapy manufacturing areas.

Responsibilities:

• Serves as a quality resource for the GMP AAV Manufacturing department directly overseeing operations in the cleanroom manufacturing environment, providing guidance and effectively communicat ing to management Quality issues that arise during the manufacturing of product.
• Perform detailed review and approval of batch records and associated documentation for AAV gene therapy manufacturing, logbooks, and other controlled documentation ensuring adherence to established procedures and cGMP regulations.
• Provide training and guidance to manufacturing personnel on quality-related topics, ensuring proper understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements.
• S upport deviations and continuous improvements related to AAV gene therapy manufacturing processes, assist with root cause analysis and identification of CAPA measures to prevent recurrence.
• Collaborate with cross-functional teams, including Process Development, Analytical Development, and Manufacturing, to support continuous process improvement initiatives and ensure alignment with quality objectives .
• Support the documentation control process for AAV gene therapy manufacturing, including reviewing and revising SOPs, work instructions, and forms to ensure compliance with regulatory requirements and industry best practices.
• Assist in the preparation for external audits and inspections, supporting regulatory agencies or client audits specific to AAV gene therapy manufacturing.

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, consistently ensuring accuracy and precision in all tasks and documentation, managing multiple priorities in a fast-paced environment
• Ability to collaborate with cross-functional technical groups to resolve issues, close gaps, and ensure compliant outcomes which are efficient and robust.
• Strong communication skills, including the ability to effectively communicate quality issues to senior management.
• Ability to work the hours necessary to support production and participate in an on-call rotation providing off-hours support for AAV manufacturing needs and issues .
• Ability to work in a GMP cleanroom environment as needed to support manufacturing operations, which includes wearing required PPE such as gowns, gloves, masks, and safety glasses.

Preferred Skills:

• Direct experience in providing QA support for cGMP manufacturing operations in a cleanroom environment .
• Experience working in the production of biologics (ex. gene therapies).
• K nowledge 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 .

Work Environment and Physical Demands

This position is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

We've Got You Covered:

• Health from day one Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
• Time to recharge A competitive paid time off plan – because rest fuels innovation.
• 12 weeks of fully paid parental leave so you can focus on family when it matters most.
• Rewarding your impact Annual bonus opportunities for all full-time team members.
• 401(k) with company match to help you plan for the future.
• Special employee discounts, including childcare and dependent care savings.
• Your wellness, supported Onsite fitness facility at The Hearth.
• Mental health counseling and financial planning services through our Employee Assistance Program.
• Employer-paid short and long-term disability coverage to protect your peace of mind.
• Fuel for your workday A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
• Grow with us Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.