---
title: 'Specialist I, QA Operations at Forge Biologics'
canonical: 'https://feeny.ai/job/specialist-i-qa-operations-forge-biologics-columbus-m3py20epzsxa'
type: 'job'
last_seen: '2026-09-10'
---

# Specialist I, QA Operations at Forge Biologics

- **Company:** Forge Biologics
- **Location:** Columbus, OH
- **Posted:** 2026-08-14
- **Last confirmed live:** 2026-09-10
- **Apply:** https://boards.greenhouse.io/forgebiologics/jobs/6126557004?gh_jid=6126557004

## Job description

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.

If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

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. This 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 communicating 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.
- Support 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).
- 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.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.

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:

At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

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.

## About Forge Biologics

## Company Overview
- **One-liner**: Forge Biologics is a US-based gene therapy CDMO (Contract Development and Manufacturing Organization) that provides AAV-focused development, cGMP manufacturing, and analytical services to accelerate therapies from concept to commercial.
- **Entity Type**: Private (subsidiary of the Ajinomoto Group)
- **Headquarters**: Columbus, Ohio, USA
- **Founded**: Not publicly available
- **Founders**: Not publicly available – the company was founded by gene therapy developers, but specific names are not disclosed [forgebiologics.com](https://www.forgebiologics.com/about/)

## Core Business
- **Primary industry**: Gene therapy contract development and manufacturing (CDMO), with a singular focus on adeno-associated virus (AAV) vectors.
- **Target customers**: Gene therapy innovators, including researchers, biotechnology companies, and pharmaceutical developers (B2B, from early discovery through commercial production).
- **Mission**: “To enable access to life-changing gene therapies by helping bring them from concept to reality” [forgebiologics.com](https://www.forgebiologics.com/about/)

## Products & Services
- **[The Hearth]**: 200,000+ sq. ft. cGMP facility with 20 custom-designed cGMP suites, bioreactors ranging from 50 to 5,000L, and dedicated space for future expansion – one of the largest AAV manufacturing sites in the world. [forgebiologics.com](https://www.forgebiologics.com/facility/)
- **[FUEL™ Technology Platform]**: Includes novel technologies such as Ignition Cells™, pEMBR™ 2.0 Ad Helper, modified rep/caps, and advanced analytics for AAV characterization – designed to improve yield, speed, and quality. [forgebiologics.com](https://www.forgebiologics.com/)
- **Development & Manufacturing Services**: End-to-end support from molecular development, product-specific process development, IND review, analytical development, and cGMP manufacturing for clinical and commercial supply. [forgebiologics.com](https://www.forgebiologics.com/)
- **Quality & Regulatory Support**: A rigorous quality organization representing 30% of the team, divided into Quality Management (QA, systems, validation) and Quality Control (analytical, microbiology, environmental monitoring). [forgebiologics.com](https://www.forgebiologics.com/facility/)

## Market Standing
- **Valuation**: Not disclosed (private subsidiary of Ajinomoto Group)
- **Key Metric**: Total funding not applicable (subsidiary); however, over 60 clients have used Forge’s technologies, and more than 600 clients have been supported across all stages. The team numbers nearly 400 experts. [forgebiologics.com](https://www.forgebiologics.com/about/)
- **Notable Investors/Partners**: Parent company Ajinomoto Group (global scale); strategic partnerships with Skylark Bio and Epicrispr Biotechnologies. [forgebiologics.com](https://www.forgebiologics.com/)
- **Growth Signals**: 
  - My Green Lab® Certification earned in June 2026, highlighting sustainability leadership among global CDMOs. [forgebiologics.com](https://www.forgebiologics.com/)
  - Designation as a Gene and Cell Therapy Hub in Columbus, Ohio, leveraging regional gene therapy innovation legacy.
  - 35+ batches manufactured to date, with ongoing scale-up for larger programs and indications.
  - 20 cGMP suites and bioreactors up to 5,000L indicate growing capacity. [forgebiologics.com](https://www.forgebiologics.com/facility/)

## Competitive Advantages
- **Singular AAV focus**: Unlike multi-modal CDMOs, Forge is dedicated exclusively to AAV vectors, enabling deeper expertise, proprietary technology (FUEL™ platform), and optimized processes.
- **Purpose-built facility**: The Hearth is one of the largest AAV-dedicated cGMP manufacturing sites globally, with 20 suites and flexible bioreactor scales for seamless scale-up/down.
- **Quality-first culture**: 30% of the team is in Quality functions, ensuring rigorous compliance and reliability for clients.
- **Scientific & Manufacturing Advisory Board**: Independent industry leaders guide innovation and best practices. [forgebiologics.com](https://www.forgebiologics.com/company/leadership/)
- **Subsidiary of Ajinomoto Group**: Access to global scale, scientific legacy, and commercial infrastructure.

## Strategic Focus
- **Scaling capacity**: Continued expansion of The Hearth to accommodate more programs and larger indications, with space for additional cGMP suites.
- **Technology leadership**: Advancing the FUEL™ platform to improve AAV manufacturing yield, purity, and speed.
- **Sustainability**: Integration of green lab practices (My Green Lab certification) as a differentiator.
- **Talent development**: Annual internship program to cultivate next-generation gene therapy scientists. [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Strategic partnerships**: Deepening collaborations with gene therapy developers (e.g., Skylark Bio, Epicrispr Biotechnologies) to support novel therapies.

## Why Work Here
- **Culture**: Driven by values of HOPE – hardworking, open, purpose-driven, and engage. Described as a diverse, passionate team redefining gene therapy manufacturing. [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Work Environment**: Flexible work environment offered, plus an onsite fitness facility & wellness center. The Hearth is designed with social hubs for connection and recharge. [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Benefits**: Medical, dental & vision insurance; generous PTO; 401K match; paid parental leave; Employee Assistance Program; bonus for every position. [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Recognition**: Forge has been named a “Best Place to Work” (recognition not further specified). [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Career Growth**: Nearly 400 employees; hands-on roles from science to operations; internship program for early talent. The company is growing rapidly.
- **Location**: Rooted in Columbus, Ohio – a region with strong gene therapy legacy, top talent, and ongoing investment. [forgebiologics.com](https://www.forgebiologics.com/facility/)
- **Job Listings**: Open roles posted on [Greenhouse](https://job-boards.greenhouse.io/forgebiologics) – candidates are cautioned against recruitment scams; Forge never asks for money or sensitive data during applications.

## Sources
1. [forgebiologics.com](https://www.forgebiologics.com/) – Main website with overview, mission, technology, and partnerships.
2. [forgebiologics.com/about/](https://www.forgebiologics.com/about/) – Company background, mission, leadership, values (HOPE), and team size.
3. [forgebiologics.com/facility/](https://www.forgebiologics.com/facility/) – The Hearth facility details (200k sq ft, 20 suites, bioreactor scales, quality organization).
4. [forgebiologics.com/careers/](https://www.forgebiologics.com/careers/) – Benefits, culture, internship program, and work environment.
5. [forgebiologics.com/company/leadership/](https://www.forgebiologics.com/company/leadership/) – Leadership team with advisory board.
6. [linkedin.com/company/forge-biologics](https://www.linkedin.com/company/forge-biologics) – LinkedIn company page for verification of size and industry.
7. [job-boards.greenhouse.io/forgebiologics](https://job-boards.greenhouse.io/forgebiologics) – Official career portal (Greenhouse) for current job openings.

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