Description:
The Environmental Monitoring Analyst will be responsible for maintaining and supporting the Environmental Monitoring (EM) and Utility Monitoring program in a GMP-regulated manufacturing facility. This role requires hands-on sampling, testing, and data analysis, along with strict adherence to regulatory and quality requirements. The candidate will also provide documentation, summaries, and support performance qualification and requalification activities.
Key Responsibilities
- Collect and test qualified Utility systems, including Clean Steam, WFI, and compressed gases
- Execute environmental sampling of Classified Areas including active air, surface, and non-viable air sampling
- Perform routine personnel monitoring and support Performance Qualification activities
- Read EM plates and perform TOC analysis, conductivity, gas testing, and LIMS submissions
- Provide accurate data entry, review, approval, and summaries of test results
- Compile and evaluate environmental data for adverse trends
- Author and summarize Requalification, Performance Qualification, and Special Study protocols
- Manage weekly and monthly sample accountability and equipment calibration
- Perform document control, filing of data sheets, and logbook maintenance
- Support investigations using GMP systems such as Trackwise, SAP, and LIMS
- Other duties as requested by management
Required Qualifications
- Associate's degree in a science field required; Bachelor's degree in Biological Sciences preferred
- At least 1 year of post-degree experience in Environmental Monitoring, Aseptic Manufacturing, or Microbiological Lab Operations
- Strong oral and written communication skills, with ability to present concepts and resolve conflicts
- Detail-oriented, flexible, and aware of production/quality control issues
- Basic understanding of GMPs and regulatory requirements for sterile pharmaceuticals or vaccines
- Ability to sit, stand, walk, perform repetitive tasks, and lift up to 50 lbs
Preferred Qualifications
- GMP experience in Environmental Monitoring (pharma setting, not EPA)
- Experience with Quality Control, Quality Assurance, and/or cGMP environments
- Prior experience with GLIMS
Important Notes
- Training Period: Flexibility required. Training may occur Mon–Fri, 8 am–5 pm EST or 4 pm–10 pm EST for 8–12 weeks before transition to the selected shift.
- Additional Screenings: Candidate must pass Varicella titer and BCG screenings before starting.
- Red Flags: Overqualification (Master's/PhD), lack of EM or microbiology experience, or background only in chemistry/biochemistry.
- Dress & Conduct: Must follow Client safety guidelines and business casual dress code. No makeup, eyelash extensions, long nails, nail polish, jewelry, or athletic clothing permitted.