Quality Control Microbiologist II

JOIN OUR TEAM AT ASCEND ADVANCED THERAPIES! At Ascend Advanced Therapies, we are dedicated to advancing innovative therapies that have the potential to transform patients' lives. Our team works collaboratively in a quality-driven, highly regulated environment to support the development and manufacturing of advanced therapeutics. We are seeking a Quality Control Microbiologist II to join our Quality Control team in Alachua, Florida. This position plays an important role in supporting microbiological testing, environmental and utility monitoring, and contamination control activities to ensure product quality, regulatory compliance, and the integrity of our GMP manufacturing processes.   Tasks and Responsibilities * Applies quality scientific techniques in the microbiological analysis of raw materials; in-process & finished product samples to include: sterility, bioburden, endotoxin, TOC & conductivity, identification, environmental monitoring, growth promotion, microbial recovery and media fill tests following approved procedures. * Executes growth promotion of microbiological media and qualification of commercially prepared organisms. * Performs environmental monitoring (including but not limited to: air, surface, and personnel) of the cleanrooms and laboratory in support of GMP manufacturing. * Performs critical utility monitoring (water and compressed air). * Assists with data analysis and trending of EM and UM data to ensure a state of control. * Provides feedback on SOPs, forms, logbooks, etc., as necessary, to facility ever-changing expectations for operating procedures and testing-related information. * Performs routine testing of products to support release and company needs. * Trains fellow QC laboratory personnel on QC test methods. * Demonstrates ability to understand and interpret test results in relation to acceptance or rejection of lot tested. * Generates data, as needed, for investigations; performs data entry for various systems and processes, and understands the necessity of trending reports. * Notifies QC Management and initiates documentation and communication of OOS and OOT results and CAPA’s, investigation reports. * Maintains appropriate gowning, aseptic technique, laboratory hygiene, and contamination prevention practices. * Performs general laboratory housekeeping and upkeep of various testing stations. * May require occasional early morning, late evening, and/or weekend work. * Supports onboarding and qualification of laboratory equipment and GMP software systems. * Purchases all necessary supplies needed for QC Microbiology. Receives supplies, logs-in and stores appropriately according to written procedures. * Assists in training staff on methods and related SOPs. * Strong computer literacy with excellent attention to detail, including document formatting and data accuracy. * Provides support for other duties, as assigned by management.   Educational Qualifications * Bachelor’s degree (BS/BA) in Microbiology, Biology, or a related field, and a minimum of 1-2  years of relevant experience or; Master’s degree in Microbiology, Biology, or a related field, and a minimum of 1 year of relevant experience. * Prior GMP experience in Microbiology related to drug substance (bulk) or drug product (fill/finish) manufacturing is preferred.   Physical Requirements * Physical demands: (check one) ☐ sedentary (< 10 lbs.)   ☐ light work (< 20 lbs.) X medium work (< 50 lbs.)   ☐ heavy work (< 100 lbs.) ☐ very heavy work (> 100 lbs.) * Physical activity: (check all that apply) X repetitive motion   X balancing   X stooping   X lifting ☐ climbing   X kneeling/crouching   ☐ crawling   X reaching X standing   X typing/grasping   X walking   X pushing/pulling ☐ hearing   * Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.) * Working conditions (indoor/outdoor, noise levels, hazards, working quarters)   Travel Requirements: (0%) Supervisor Responsibilities: This position does not require previous supervisory experience.