Quality Control Microbiologist II
About The Position
Ascend Advanced Therapies is seeking a Quality Control Microbiologist II to join its Quality Control team in Alachua, Florida. The position supports microbiological testing, environmental and utility monitoring, and contamination control to help ensure product quality, regulatory compliance, and the integrity of GMP manufacturing processes. The role works in a quality-driven, highly regulated environment supporting the development and manufacturing of advanced therapeutics. The Quality Control Microbiologist performs testing and monitoring, analyzes and trends data, supports investigations and documentation, maintains aseptic practices and laboratory operations, and assists with training, equipment and software qualification, and laboratory supply management. Occasional early morning, late evening, and/or weekend work may be required. The position has no supervisory responsibilities and lists travel requirements as 0%.
Requirements
- Bachelor’s degree in Microbiology, Biology, or a related field and 1–2 years of relevant experience, or a master’s degree in one of those fields and at least 1 year of relevant experience.
- Strong computer literacy and excellent attention to detail, including document formatting and data accuracy.
- Ability to perform the listed physical activities, including repetitive motion, balancing, stooping, lifting, kneeling or crouching, reaching, standing, typing or grasping, walking, and pushing or pulling.
- Ability to work occasional early mornings, late evenings, and/or weekends.
Nice To Haves
- Prior GMP microbiology experience related to drug substance (bulk) or drug product (fill/finish) manufacturing.
Responsibilities
- Performs microbiological analysis of raw materials, in-process samples, and finished products, including sterility, bioburden, endotoxin, TOC and conductivity, identification, environmental monitoring, growth promotion, microbial recovery, and media fill testing according to approved procedures.
- Executes growth promotion of microbiological media and qualification of commercially prepared organisms.
- Performs environmental monitoring of cleanrooms and laboratories, including air, surface, and personnel monitoring, in support of GMP manufacturing.
- Performs critical utility monitoring of water and compressed air.
- Assists with analysis and trending of environmental monitoring and utility monitoring data to ensure a state of control.
- Provides feedback on SOPs, forms, logbooks, and other testing-related information as needed.
- Performs routine product testing to support product release and company needs.
- Trains QC laboratory personnel on QC test methods and assists with training staff on methods and related SOPs.
- Interprets test results in relation to acceptance or rejection of the tested lot.
- Generates data for investigations, performs data entry for systems and processes, and supports trending reports.
- Notifies QC Management and initiates documentation and communication for OOS and OOT results, CAPAs, and investigation reports.
- Maintains appropriate gowning, aseptic technique, laboratory hygiene, and contamination prevention practices.
- Performs general laboratory housekeeping and maintains testing stations.
- Supports onboarding and qualification of laboratory equipment and GMP software systems.
- Purchases necessary QC Microbiology supplies; receives, logs, and stores supplies according to written procedures.
- Provides support for other duties as assigned by management.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
