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

Forge Biologics

Columbus (OH)

On-site

USD 45,000 - 65,000

Full time

6 days ago

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Benefits offered by this job

Health, dental and vision insurance

401(k) with company match

Paid time off

Parental leave

Onsite fitness facility

Mentorship and training

Job summary

Forge Biologics in Columbus, OH is seeking a QC Analyst I (EM & Micro) to support the Environmental Monitoring program and the aseptic manufacturing environment. You will perform EM sampling, support microbial testing, and help ensure GMP compliance in a state-of-the-art facility.

The role requires strong attention to detail, ability to work second shift, and readiness to train junior staff while meeting production schedules. Join a team committed to advancing gene therapies.

Qualifications

High School diploma or GED required; Bachelor’s in microbiology/biology preferred.
1–2 years’ GMP or QC experience strongly preferred.
Self-motivated, organized, and proactive.
Strong technical aptitude and problem-solving abilities.
Ability to work hours to support QC and production.
Aseptic techniques knowledge preferred.

Responsibilities

Performs EM sampling applying GMP principles and methodologies.
Conduct environmental monitoring of air, surface, and personnel in sterile areas.
Support trending EM data using JMP and LIMS.
Perform microbial testing including Gram-stain, growth promotion, endotoxin, bioburden, osmolality, pH, etc.
Assist investigations to determine root cause of OOS and implement CAPA.
Train junior staff in laboratory skills and EM sampling.
Plan work to meet production and client schedules.
Prepare EM data forms and labels and execute EM testing.
Deliver results in a fast-paced environment.
Participate in Media Fill/APS qualifications.
Perform other duties as assigned.

Skills

GMP experience

Laboratory experience

Microbiology knowledge

Attention to detail

Self-motivation

Documentation skills

Education

Bachelor’s degree in microbiology or biology

High School Diploma or GED

Tools

JMP

LIMS

Job description

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

Columbus, Ohio

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’seg: JMP and LIMS.
Performing microbial testing including but not limited to: Gram-stain, Growth promotion, Endotoxin, Bioburden, Osmolality, pH, etc.
Supports thorough investigations todetermineroot cause of OOSinvestigations inthe implementation ofappropriate correctiveand preventative actionsin 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, EMlabels,and executes the EM testing.
Deliver results in a fast‑paced environment.
Participates in Media Fill/AsepticProcessSims(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 fieldpreferred.
Minimum 1-2 years’ experience in a GMP or QC environmentis stronglypreferred.
Must be self‑motivated, organized, and proactive.
Strong technical aptitude, includingdemonstratedexperience in applying scientific reasoning to solve complex problems.
Ability to work hours necessary to support QC and production
Job activities requirelong periodsof standing and use of controlled movements as wellasaseptic techniques/behaviors in the sterile filling suites.
Knowledge of aseptictechniquespreferred.
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,surfaceand 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.

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.
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