Quality Control Analyst I

Forge Biologics•Columbus, OH

23d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.

Benefits

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.