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

Forge Biologics•Columbus, OH

6d•Onsite

About The Position

The QC Analyst I (EM & Micro) supports Forge Biologics’ Environmental Monitoring (EM) program and routine QC microbiology laboratory testing. The role helps maintain the aseptic manufacturing environment and ensure compliance with GMP standards, applying knowledge of cleanroom behavior, sterile gowning, and aseptic sampling. The position performs environmental monitoring and microbial testing, supports data trending and investigations, and helps coordinate work to meet production and client schedules. It also participates in Media Fill/Aseptic Process Simulation qualifications and may train junior staff in laboratory skills and EM sampling schedules. The role works in both laboratory and manufacturing cleanroom environments.

Requirements

High school diploma or GED equivalent required.
Must be self-motivated, organized, and proactive.
Strong technical aptitude, including demonstrated ability to apply scientific reasoning to solve complex problems.
Ability to work the hours necessary to support QC and production activities.
Ability to work independently with minimal supervision.
Ability to stand for long periods and use controlled movements and aseptic techniques or 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 personal protective equipment and sterile cleanroom gowning as needed.
Ability to identify small details within the field of vision, distinguish colors, and accurately identify objects within a specific area.

Nice To Haves

Bachelor’s degree in microbiology, biology, or a related scientific field.
One to two 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 performing 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 scheduling environmental monitoring sampling.
Plan work to meet production and internal and external client schedule requirements.
Prepare environmental monitoring data forms and labels, and execute environmental monitoring testing.
Participate in Media Fill/Aseptic Process Simulation 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 plan.
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.