SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Forge Biologics is seeking a QC Analyst I to support the Environmental Monitoring (EM) program at The Hearth, a state-of-the-art 200,000-square-foot cGMP manufacturing facility in Columbus, Ohio. This role is critical to ensuring compliance with GMP standards in aseptic manufacturing environments.
As a QC Analyst I, you will be a supporting contributor to EM initiatives and QC microbiology lab routine testing. You will work the 2nd shift and play a key role in maintaining the sterile manufacturing environment that enables the production of life-changing gene therapies.
Key Responsibilities:
- Perform EM sampling incorporating GMP principles and methodologies
- Conduct environmental monitoring activities including air, surface, and personnel monitoring 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 related assays
- Support thorough investigations to determine root cause of out-of-specification (OOS) results and implement appropriate corrective and preventative actions
- 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 and Aseptic Process Simulation (APS) qualifications
The ideal candidate will demonstrate a strong understanding of cleanroom behavior, sterile gowning, and aseptic sampling techniques. This position offers the opportunity to contribute directly to bringing hope to patients with genetic diseases while working alongside a purpose-driven team.
Forge Biologics offers comprehensive benefits including health, dental, and vision insurance (90% premium coverage), competitive paid time off, 12 weeks of fully paid parental leave, annual bonuses, 401(k) with company match, onsite fitness facility, mental health and financial planning services, employer-paid disability coverage, and professional development resources.
Requirements:
The posting does not explicitly state specific years of experience, educational credentials, or certifications required for this role. Candidates should possess knowledge of GMP principles, familiarity with cleanroom operations, and laboratory testing experience. Proficiency with data management software (JMP, LIMS) and microbiology testing techniques is expected.
