Quality Systems Specialist I

About Forge

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 idea 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.

About the Role

The Quality Systems Specialist I will provide expertise and guidance in authoring, reviewing, and approving quality events such as deviations, CAPAs, change controls, and investigations. The Quality Systems Specialist will also be responsible for monitoring and improving the internal quality systems policies and workflows at Forge.

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. This role must demonstrate accountability, transparency, and effective communication cross-functionally and within the Quality team.

What You'll Do

• Serve as a quality resource for QMS elements, including deviations, CAPAs, change controls, and investigations.
• Support the authoring, review, and approval of quality events and associated documentation.
• Ensure compliance with Good Documentation Practices (GDP) and cGMP expectations in all quality system workflows.
• Conduct root cause analysis (RCA) activities and assist in developing effective, sustainable CAPA plans.
• Partner with internal stakeholders to identify and implement continuous improvement initiatives.
• Author or review controlled documentation, including Standard Operating Procedures (SOPs), Work Instructions, and Forms.
• Participate in cross-functional meetings to close gaps, resolve issues, and align on quality-compliant solutions.
• Assist in internal and external audit preparation and execution as needed.

What You'll Bring

• Bachelor's Degree (B.A. or B.S.) in biological or STEM-related field (or equivalent work experience)
• Thorough knowledge and application of Good Documentation Practices (GDP).
• Experience in a GxP environment.
• Must be self-motivated, organized, and proactive.
• Demonstrated knowledge and understanding of cGMP regulations and Food and Drug Administration (FDA) and EU requirements/guidance documents.
• Ability to maintain a high degree of accuracy and attention to detail.
• Ability to deliver results in a fast-paced, multi-tasking environment, and prioritize objectives effectively.

Preferred Skills

• Experience with root cause analysis and investigations, including technical writing skills.
• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
• Knowledge of biopharmaceutical manufacturing process workflows.
• Experience supporting inspections performed by FDA and foreign Regulatory Authorities.
• Familiarity within a pharmaceutical, biotech, or related industry.
• Sterile injectable pharmaceuticals or biologics experience is preferred.
• Experience with Veeva Vault QMS.

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 works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

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.

Forge Your Future with Us

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.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
• Competitive PTO (plus 14 paid company holidays)
• Annual bonus for all full-time employees
• 401(K) company match
• Fully-stocked kitchen with free food/drinks
• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Employee Assistance Programs
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Professional & Personal development resources