Quality Control Analyst

The QC Analyst II is responsible for environmental monitoring (EM) and microbiological testing in GMP aseptic and non-sterile manufacturing environments, including high-potency API operations. This role supports product quality and patient safety through accurate testing, documentation, and close collaboration with Manufacturing and Quality Assurance.

• Perform environmental monitoring in clean rooms using particle counters, contact plates, swabs, and microbial air samplers
• Conduct utility water sampling and testing (conductivity, TOC, endotoxin, bioburden)
• Perform microbiological testing including endotoxin, growth promotion, and microbial identification
• Log samples, assign tracking numbers, and coordinate external lab testing
• Accurately document results in worksheets, notebooks, and electronic systems (LIMS) in compliance with ALCOA+ and cGMP
• Support aseptic process validations and gowning certifications
• Review data packets, SOPs, and controlled documents for accuracy and compliance
• Perform routine lab and equipment maintenance
• Collaborate cross-functionally and support special projects as needed

• Bachelor’s degree in Microbiology, Biology, or a related life sciences discipline
• 2+ years of experience performing microbiological testing in a GMP environment
• Hands-on experience with environmental monitoring, aseptic manufacturing, and pharmaceutical water systems
• Strong attention to detail, documentation skills, and ability to work independently

• Ability to stand or sit for extended periods
• Ability to lift up to 25 pounds
• Vision requirements include close, distance, color, and depth perception