Environmental Monitoring - QC Analyst III

About the role

A top-performing pharmaceutical manufacturer recognized for its exceptional workplace culture, is seeking a QC Analyst III – Environmental Monitoring (EM) to join its Quality Control team. This is a unique opportunity to work in a sterile manufacturing environment where you'll have a direct impact on product quality, patient safety, and operational excellence while partnering with a highly collaborative and supportive team!

Responsibilities

• Perform routine, batch-related, and quarterly environmental monitoring in aseptic, classified, and controlled manufacturing areas.
• Collect environmental monitoring samples in cleanroom environments.
• Support sterile manufacturing operations through production observations and cleanroom walkthroughs.
• Maintain compliance with aseptic techniques and contamination control strategies.
• Perform utilities sampling and testing of:
• Water for Injection (WFI)
• Purified Water (PW)
• Potable/City Water
• Compressed Air
• Nitrogen and other process gases
• Conduct microbiological testing including:
• Endotoxin (Required)
• Bioburden (Required)
• TOC (Preferred)
• Conductivity (Preferred)
• Enumerate organisms from environmental and utility samples.
• Author, revise, and maintain:
• SOPs
• Risk Assessments
• Change Controls
• Protocols
• Technical Reports
• Support investigations, deviations, and corrective actions.
• Review technical documentation from internal stakeholders.
• Maintain documentation in accordance with GMP requirements.
• Train manufacturing and environmental monitoring personnel.
• Support gowning qualifications and annual requalification activities.
• Mentor junior team members and serve as a technical resource within the department.
• Represent the department during meetings, audits, and cross-functional initiatives.

Qualifications

• Education: Bachelor's Degree in Biology, Microbiology, Life Sciences, or a related scientific discipline preferred.
• Experience: 5+ years of pharmaceutical microbiology, QC, or Environmental Monitoring experience.
• Experience supporting sterile manufacturing operations.
• Environmental Monitoring (EM) and cleanroom sampling experience.
• Aseptic gowning and sterile gowning qualification experience.
• Utilities sampling and testing experience.
• Required: Endotoxin and Bioburden testing.
• Experience with water systems (WFI, Purified Water, Potable Water) and compressed gases (air and nitrogen).