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

The role

The QC Analyst I supports the Environmental Monitoring program and the aseptic manufacturing environment. This role involves supporting EM initiatives and routine QC microbiology lab testing.

What you will do

• Performs EM sampling using GMP principles and methodologies.
• Conducts environmental monitoring for air, surface, and personnel in sterile manufacturing areas.
• Supports trending of EM data using JMP and LIMS.
• Performs microbial testing including Gram-stain, Growth promotion, Endotoxin, Bioburden, Osmolality, and pH.
• Supports investigations to determine root cause of OOS investigations.
• Trains junior staff in laboratory skills and EM sampling scheduling.
• Plans work to meet production and client schedule requirements.
• Prepares EM data forms and labels and executes EM testing.
• Participates in Media Fill/Aseptic Process Sims (APS) qualifications.
• Performs other duties as assigned.

Required qualifications

• Minimum of a High School Diploma or GED equivalent
• Must be self-motivated, organized, and proactive
• Strong technical aptitude and experience applying scientific reasoning to solve complex problems
• Ability to work hours necessary to support QC and production
• Long periods of standing and use of controlled movements
• Aseptic techniques/behaviors in sterile filling suites
• Ability to work in confined spaces like clean rooms and near operating equipment
• Ability to work in loud noise environments
• Ability to work in Personal Protective Equipment (PPE) and Clean Room sterile gowning attire
• Ability to work independently with minimal supervision
• Ability to identify small details within the field of vision
• Ability to distinguish between different colors and accurately identify objects

Nice to have

• Bachelor’s degree in microbiology, Biology, or a related scientific field
• Minimum 1-2 years’ experience in a GMP or QC environment
• Knowledge of aseptic techniques
• Experience in a GMP environment or other regulated industry
• Prior experience of environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas
• Prior experience performing microbial testing including Gram-stain, Growth promotion, Endotoxin, Bioburden, Osmolality, pH, etc.

Benefits

• Health, dental and vision insurance start on first day 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

About the company

Forge Biologics aims to enable access to life-changing gene therapies. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.