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. Perform TOC testing of water samples Perform bioburden and Endotoxin testing of incoming raw materials 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. Assist in investigations of out-of-specification (OOS) results and other microbiology-related deviations. Comply with cGMP requirements and documented policies at all times. | |||
| Skills: | Bachelor's degree in Microbiology (preferred) with minimum of 2 years of experience in a QC Microbiology laboratory or equivalent combination of education and experience. Experience in the application of microbiological techniques such as air monitoring gases, water testing, surface monitoring. Experience in sterile gowning procedures, aseptic techniques and clean room operations is a plus Knowledge of GMP, SOPs and quality control processes Experience with LIMS (i.e. MODA) and Sievers M9s for TOC testing is a plus Proficient in MS Office and other applications. Excellent interpersonal, verbal and written communication skills are in this collaborative work environment. Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Candidates must be authorized to work in the U.S. | ||
| Education: | Bachelor's degree in Microbiology (preferred) | ||