QC Analyst 1 - QC, Micro & EM

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.

Position Overview:  

QC Analyst I (EM &Micro) will be a supporting contributor to the Environmental Monitoring (EM) program, supporting the aseptic manufacturing environment and ensuring compliance with GMP standards. The Analyst I will support EM initiatives and QC microbiology lab routine testing. This position also requires a good understanding of cleanroom behavior, sterile gowning, and aseptic sampling.

Responsibilities:

• Performs EM sampling that incorporates application of GMP principles and methodologies. 

• Conduct environmental monitoring activities including air, surface, and personnel inside the sterile manufacturing areas. 

• Support trending of EM data using software’s eg: JMP and LIMS.

• Performing microbial testing including but not limited to: Gram-stain, Growth promotion, Endotoxin, Bioburden, Osmolality, pH, etc. 

• Supports thorough investigations to determine root cause of OOS investigations in the implementation of appropriate corrective and preventative actions in a timely manner. 

• Trains junior staff in laboratory skills and scheduling EM sampling. 

• Plans work to meet production and schedule requirements from clients (internal and external). 

• Prepares EM data forms, EM labels, and executes the EM testing. 

• Deliver results in a fast-paced environment. 

• Participates in Media Fill/Aseptic Process Sims (APS) qualifications. 

• Perform other duties as assigned

Qualifications:

• Minimum of a High School Diploma or GED equivalent required. Bachelor’s degree in microbiology, Biology, or a related scientific field preferred. 

• Minimum 1-2 years’ experience in a GMP or QC environment is strongly preferred. 

• Must be self-motivated, organized, and proactive. 

• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems. 

• Ability to work hours necessary to support QC and production 

• Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites. 

• Knowledge of aseptic techniques preferred. 

• Ability to work in confined spaces like clean rooms and near operating equipment. 

• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room sterile gowning attire as needed. 

• Ability to work independently with minimal supervision. 

Preferred Skills:

• Knowledge of aseptic techniques and behavior.

• Experience in a GMP environment or other regulated industry.

• Prior experience of environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas.

• Prior experience performing microbial testing including but not limited to: Gram-stain, Growth promotion, Endotoxin, Bioburden, Osmolality, pH, etc.

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 manufacturing cleanroom environment where the physical 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.