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

Forge Biologics•Columbus, OH

7d•Onsite

About The Position

The QC Analyst I (EM & Micro) supports the Environmental Monitoring (EM) program, aseptic manufacturing, and routine QC microbiology testing while helping ensure compliance with GMP standards. The role requires understanding of cleanroom behavior, sterile gowning, and aseptic sampling. The position works in both laboratory and manufacturing cleanroom environments and may involve standing or sitting for extended periods, wearing task-appropriate PPE, and working in confined spaces.

Requirements

High school diploma or GED equivalent.
Self-motivated, organized, and proactive.
Strong technical aptitude, including the ability to apply scientific reasoning to solve complex problems.
Ability to work the hours necessary to support QC and production.
Ability to work independently with minimal supervision.
Ability to stand or sit for extended periods and use controlled movements while performing aseptic techniques and behaviors in sterile filling suites.
Ability to work in confined spaces such as cleanrooms and near operating equipment.
Ability to work in loud environments and wear PPE and sterile cleanroom gowning attire as needed.
Ability to identify small visual details, distinguish colors, and accurately identify objects within a specific area.

Nice To Haves

Bachelor’s degree in microbiology, biology, or a related scientific field.
1–2 years of experience in a GMP or QC environment.
Knowledge of aseptic techniques and behavior.
Experience in a GMP environment or other regulated industry.
Prior experience conducting environmental monitoring of air, surfaces, and personnel in sterile manufacturing areas.
Prior experience performing microbial testing, including Gram stain, growth promotion, endotoxin, bioburden, osmolality, and pH testing.

Responsibilities

Perform environmental monitoring sampling using GMP principles and methodologies.
Conduct air, surface, and personnel monitoring inside sterile manufacturing areas.
Support trending of environmental monitoring data using software such as JMP and LIMS.
Perform microbial testing, including Gram stain, growth promotion, endotoxin, bioburden, osmolality, and pH testing.
Support investigations to determine root causes of out-of-specification results and implement appropriate corrective and preventive actions in a timely manner.
Train junior staff in laboratory skills and environmental monitoring scheduling.
Plan work to meet production and client scheduling requirements.
Prepare environmental monitoring data forms and labels, and execute environmental monitoring testing.
Deliver results in a fast-paced environment.
Participate in Media Fill/Aseptic Process Simulations (APS) qualifications.
Perform other duties as assigned.

Benefits

Health, dental, and vision insurance beginning on the first day, with 90% of premiums covered for the employee and family.
Competitive paid time off.
12 weeks of fully paid parental leave.
Annual bonus opportunities for full-time team members.
401(k) with company match.
Employee discounts, including childcare and dependent care savings.
Onsite fitness facility.
Mental health counseling and financial planning services through the Employee Assistance Program.
Employer-paid short- and long-term disability coverage.
Fully stocked kitchen with free snacks and beverages.
Professional development resources, training, and mentorship programs.