Microbiology & Environmental Monitoring Analyst

About The Role

A growing life sciences company is seeking a Microbiology Analyst to join its Quality Control team at either a Level I or Level II capacity depending on experience. Both levels will contribute hands-on to environmental monitoring, microbiological testing, and GMP compliance activities supporting a sterile manufacturing environment. This is an excellent opportunity for a self-motivated scientist who thrives in a collaborative, fast-paced setting.

Responsibilities

The following responsibilities apply to both levels, with Level II expected to operate with greater independence and take on additional ownership:

• Execute environmental monitoring programs across facilities and utilities, including viable and non-viable air and gas sampling, surface sampling, water sampling and testing, and personnel monitoring.
• Perform sterility and endotoxin testing on drug product and other compendial microbiological tests as required.
• Perform bioburden and endotoxin testing on incoming raw materials.
• Conduct aerobic and anaerobic plate count readouts, interpret results, and generate associated reports.
• Carry out media growth promotion testing, gram staining, and isolate preparation for organism identification.
• Perform TOC testing of water samples using applicable instrumentation.
• Enter, monitor, and trend data within a LIMS platform; assemble EM reports and provide regular updates on environmental trends to management.
• Support out-of-specification investigations and microbiology-related deviations.
• Maintain laboratory operations in a GMP-compliant state, coordinating with internal and external partners to ensure adequate supplies and properly functioning equipment.
• Collect metrics to support continuous improvement initiatives within areas of responsibility.

Level II Additional Responsibilities

• Develop and implement corrective action plans as needed following deviation investigations.
• Review and revise SOPs and support the document change control process.
• Provide management with regular trend analysis and environmental monitoring summaries.

Qualifications

Level I

• Bachelor's degree in Microbiology or a related life sciences field; Microbiology preferred.
• Minimum 2 years of experience in a QC Microbiology laboratory within a regulated environment; equivalent combinations of education and experience will be considered.
• Experience with microbiological techniques including air monitoring, water testing, and surface sampling.
• Familiarity with GMP, SOPs, and quality control processes.
• Experience with sterile gowning, aseptic technique, and cleanroom operations a plus.
• Experience with LIMS platforms (e.g. MODA) and TOC instrumentation (e.g. Sievers M9s) a plus.

Level II

• Minimum 3 years of experience in a QC Microbiology laboratory within a regulated environment.
• Demonstrated experience with environmental monitoring techniques including viable/non-viable air and gas monitoring, water bioburden testing, surface sampling, and personnel monitoring.
• Hands-on experience with core microbiological techniques: aseptic technique, media growth promotion, microbial enumeration, gram staining, and isolate handling.

Both Levels

• Proficient in MS Office Suite
• Strong written and verbal communication skills; ability to collaborate effectively across QC and Manufacturing teams
• Ability to prioritize and manage workload independently in a dynamic, fast-paced environment
• Must be authorized to work in the United States