Environmental Monitoring III

Position Summary

We are seeking a QC Analyst III with strong microbiology and environmental monitoring expertise to support sterile manufacturing operations. This role is a mix of hands-on lab testing and on-the-floor sampling (50%) and technical documentation, SOP work, and deviation support (50%) within a GMP-regulated environment.

Key Requirements (Must-Haves)

• Strong Environmental Monitoring (EM) experience is REQUIRED
• 5–6+ years in Microbiology, Biology, Biochemistry, or related field
• Experience in aseptic / sterile manufacturing environments
• Hands-on utility sampling (especially water systems )
• GMP experience with deviation investigations and SOP writing/review
• Experience with bioburden, endotoxin, and conductivity testing (2/3 is good)
• Strong aseptic gowning and Grade A/B cleanroom experience

Key Responsibilities

• Perform environmental monitoring in aseptic and sterile manufacturing areas
• Conduct utility sampling and testing, including water and compressed gas systems
• Perform microbiological testing such as bioburden, endotoxin, and conductivity testing
• Work in Grade A/B aseptic environments with proper gowning procedures
• Execute routine floor sampling and laboratory-based testing activities
• Write, review, and revise SOPs, GMP documentation, and technical reports
• Support and lead deviation investigations and root cause analysis
• Maintain chain of custody and sample tracking documentation
• Participate in risk assessments and quality investigations
• Collaborate with a QC team supporting both OSD and sterile manufacturing

Preferred Qualifications

• Experience training or mentoring others in a QC environment
• Exposure to TLC or broader analytical microbiology techniques
• Strong experience in technical writing and document control systems
• Familiarity with risk assessments and continuous improvement initiatives