QC Analyst I, QC - Micro & EM(2nd Shift)

About the role

Forge Biologics is a gene therapy CDMO with a mission to enable access to life-changing gene therapies and help bring them from ideas into reality. The team operates from The Hearth, a 200,000‑square‑foot cGMP facility in Columbus, Ohio. The culture is built on H.O.P.E.: Hardworking, Open, Purpose‑driven, and Engaged. The company invests in employee growth through mentorship, hands‑on learning, and advancement opportunities.

The QC Analyst I (EM & Micro) supports the Environmental Monitoring (EM) program for aseptic manufacturing, ensuring GMP compliance. The role performs EM sampling, routine QC microbiology testing, data trending, investigations, and participates in media fills and aseptic process simulations. This position requires cleanroom experience, sterile gowning, aseptic technique, and the ability to work in a fast‑paced, regulated environment.

Responsibilities

• Perform EM sampling applying GMP principles and methodologies
• Conduct environmental monitoring activities including air, surface, and personnel sampling inside sterile manufacturing areas
• Support trending of EM data using software such as JMP and LIMS
• Perform microbial testing including Gram‑stain, growth promotion, endotoxin, bioburden, osmolality, pH, and other assays
• Support thorough investigations to determine root cause of OOS results and implement appropriate corrective and preventive actions in a timely manner
• Train junior staff in laboratory skills and EM sampling scheduling
• Plan work to meet production and schedule requirements from internal and external clients
• Prepare EM data forms, EM labels, and execute EM testing
• Deliver results in a fast‑paced environment
• Participate in Media Fill / Aseptic Process Simulation (APS) qualifications
• Perform other duties as assigned

Qualifications

• Minimum 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 strongly preferred
• Self‑motivated, organized, and proactive
• Strong technical aptitude with demonstrated experience applying scientific reasoning to solve complex problems
• Ability to work hours necessary to support QC and production activities
• Job requires long periods of standing, controlled movements, and aseptic techniques/behaviors in sterile filling suites
• Knowledge of aseptic techniques preferred
• Ability to work in confined spaces such as cleanrooms and near operating equipment
• Ability to work in loud noise environments while wearing PPE and cleanroom sterile gowning attire
• Ability to work independently with minimal supervision

Skills

• Knowledge of aseptic techniques and behavior
• Experience in a GMP environment or other regulated industry
• Prior experience with environmental monitoring activities (air, surface, and personnel sampling in sterile manufacturing areas)
• Prior experience performing microbial testing including Gram‑stain, growth promotion, endotoxin, bioburden, osmolality, pH, and related assays

Work environment and physical demands

• Works in both laboratory and manufacturing cleanroom environments; physical demands vary by task
• Stationary (standing/sitting) for extended periods
• Regularly wears personal protective equipment based on task
• Must be able to work in confined spaces such as cleanrooms or laboratories
• Ability to identify small details within the field of vision, distinguish between colors, and accurately identify objects within a specific area

Benefits

• Health, dental, and vision insurance effective day one with 90% of premiums covered for employee and family
• Competitive paid time off plan
• 12 weeks of fully paid parental leave
• Annual bonus opportunities for all full‑time team members
• 401(k) with company match
• Special employee discounts including childcare and dependent care savings
• Onsite fitness facility at The Hearth
• Mental health counseling and financial planning services through Employee Assistance Program
• Employer‑paid short‑ and long‑term disability coverage
• Fully stocked kitchen with free snacks and beverages
• Ongoing professional development resources, training, and mentorship programs