Environmental Monitoring - QC Analyst III

QC Analyst III – Environmental Monitoring (EM)

Location: Dayton, OH

Schedule: Monday–Friday | 8:00 AM – 5 PM

Employment Type: Perm Hire, Full-Time

Salary: $70,000 – $84,000 + Annual Bonus

Relocation Assistance: Available

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!

• 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.
• Monitor 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.

• Bachelor's Degree in Biology, Microbiology, Life Sciences, or a related scientific discipline preferred.

• 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).