What are the responsibilities and job description for the Environmental Monitoring III position at Harba Solutions Inc.?
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