Quality Control Analyst I

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. 

 

Summary: 

We are currently seeking an Analyst I, Quality Control (QC) - Environmental Monitoring & Microbiology to join the Forge Biologics team. This is an exciting opportunity to join our QC team and to lead and contribute to the production of life-changing gene therapies for human use. This role is responsible for conducting microbiological testing and environmental monitoring (EM) of cleanrooms within our facility, while also providing hands-on support for the implementation of new technologies and systems in our GMP manufacturing facility.

 

Responsibilities:

• Conduct various microbiological tests in a laboratory setting, including Gram staining, Endotoxin analysis, Bioburden determination, Osmolality measurements, and pH testing.
• Execute environmental monitoring activities by collecting air and surface samples within designated cleanroom areas to ensure compliance with regulatory standards.
• Assist in analyzing Environmental Monitoring data trends using software such as JMP and LIMS to identify potential areas for improvement or compliance issues.
• Participate in thorough investigations to determine the root cause of OOS results and contribute to the implementation of corrective and preventive actions in a timely manner.
• Develop and implement work plans to meet production and scheduling requirements from both internal and external clients, ensuring timely completion of tasks.
• Prepare microbiological equipment, samples, environmental monitoring data forms, and labels for testing, ensuring accuracy and compliance with protocols.
• Collaborate in Media Fill, Process Simulation, and Smoke Studies to evaluate and validate manufacturing processes and equipment performance.

Qualifications:

• Bachelor's Degree in Microbiology, Biology or related scientific field (or equivalent work experience).
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines. 
• Good interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders. 
• Ability to adapt to changing priorities and work independently as well as part of a team. 
• Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules.

Preferred Skills/Experience:

• Knowledge of aseptic technique or behavior.
• Experience in a GxP environment or other regulated industry.
• Prior experience performing microbial testing including but not limited to: Gram-stain, Endotoxin, Bioburden, Osmolality, pH, etc.

 

Physical Requirements:

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.  

   

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.