• Perform environmental monitoring of utilities and facilities, including air and gas monitoring (viable and non-viable), surface sampling, water sampling and testing, and personnel monitoring.
• Perform endotoxin and sterility testing on final drug product and other compendial tests as needed.
• Perform aerobic and anaerobic plate count readout, analysis, and reporting.
• Perform media growth promotion testing, gram staining, and isolate preparation for microbial identification.
• Work with internal and external partners to keep the laboratory operating optimally, including ensuring adequate supplies and maintaining equipment in a GMP-compliant state.
• Enter data into the MODA LIMS, monitor and trend data, assemble reports on environmental monitoring findings, provide management with regular updates on environmental trends, own and implement corrective action plans as needed.
• Revise and review SOPs and support document change control as needed.
• ssist in investigations of out-of-specification (OOS) results and other microbiology-related deviations.
• Comply with cGMP requirements and documented policies at all times.
• Gather metrics to support continuous improvement in areas of responsibility.
• Other duties as assigned.
Skills:
• Bachelor's degree in Microbiology (preferred) or related field with a minimum of 3 years of experience in a QC Microbiology laboratory or equivalent combination of education and experience.
• Experience in the application of microbiological environmental monitoring techniques such as viable and non-viable monitoring of air and gases, water sample collection and testing, viable surface sampling, and personnel monitoring.
• Experience in sterile gowning procedures, aseptic techniques, and clean room operations.
• Experience in the performance of "core" microbiological laboratory techniques including aseptic techniques, growth promotion of media, enumeration/observation of microbial growth, gram staining, and isolate handling.
• Experience performing bioburden testing of water.
• Knowledge of cGMPs and Quality Control processes.
• Experience with LIMS (i.e. MODA, Labvantage) is a plus.
• Proficient in MS Office and other applications.
• Excellent interpersonal, verbal, and written communication skills are required in this collaborative work environment.
• Comfortable in a fast-paced, small company environment with minimal direction and the ability to adjust workload based upon changing priorities.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines.
• bility to work independently and as part of a team within the Quality Control and in collaboration with Manufacturing teams.
• Candidates must be authorized to work in the U.S.
