Microbiologist Position Available In Broward, Florida
Tallo's Job Summary: This Microbiologist role involves providing microbiological support for manufacturing and support activities. Responsibilities include performing various microbiological testing, data analysis, archiving, and mentoring staff. The ideal candidate will have a B.S. in a scientific discipline, 3-5 years of experience in an FDA/EMA regulated environment, and strong investigation skills. The work environment follows cGMP standards and requires working in cleanroom conditions.
Job Description
Job Title:
Microbiologist Job Description This role provides microbiological support for manufacturing and support activities, including environmental monitoring, media fills, microbiological and chemical sampling, and other essential tasks. The position involves performing various microbiological and related testing such as bio burden, BET, MLT, microbial identification, sterility, TOC, pH, conductivity, utility monitoring, and growth promotion. Additionally, it includes conducting quarterly and annual data analysis, archiving, and trending of environmental monitoring and utilities data, as well as mentoring microbiology staff. Responsibilities Perform microbiology tests and reports. Maintain, review, and approve equipment log books. Ensure the microbiology area is tidy, organized, and sanitary. Ensure sufficient quantities and shelf-life of microbiological supplies. Create, execute, and compile verification protocols and reports. Lead laboratory investigations for OOS microbiological testing results and non-conformances. Prepare deviations, investigations, OOS, change control, work orders, and test reports. Create or revise departmental SOPs. Maintain quarterly reports for the microbiology lab tracking alerts, actions, or OOS. Optimize procedures and methods for microbiological monitoring. Maintain microbiological results and reports, track trends and metrics. Monitor compendia and standards to ensure current procedures and processes. Assist in vendor audits at the request of the Quality Assurance Department. Stay current with FDA, EMA, and CGMP standards and industry trends. Essential Skills Proficiency in microbiological techniques (bio burden, sterility, endotoxin, TOC, water testing, environmental monitoring, growth promotion, visual inspections). Excellent verbal and written communication skills. Subject matter expertise in aseptic technique and processing. Ability to work independently with excellent judgment and integrity. Additional Skills & Qualifications B.S. in a scientific discipline. 3 to 5 years of experience in an FDA/EMA regulated environment. Strong investigation skills. Work Environment The work environment adheres to cGMP standards and involves working in cleanroom conditions.