The Microbiologist is responsible for the implementation of the microbiological control program at iLabs to ensure production meets the requirements of the microbiological standards and operating procedures. Microbiological control programs include, but are not limited to: Current Good Manufacturing Practices (cGMPs), environmental monitoring, raw materials, bulk and finished product testing & release, and corrective and preventive actions.Job Type:
- Demonstrates the use of aseptic technique
- Must utilize proper personal protective equipment (PPE) when handling all samples as well as biohazard
- Performs Microbiological testing of Raw Materials/Bulk Products/Finished Products, stability for R&D samples and documentation as per procedure
- Performs microbiological testing related for the following microbiological test methods: Microbial Enumeration and Specified Microorganism (MET/SMT) testing per USP 60, 61/62
- Performs Antimicrobial Effectiveness Testing (AET) per USP 51
- Performs Preservative Effectiveness Testing (PET) per USP 51
- Sampling and Microbiological testing of water as per the procedure
- Performs Purified/Source Water testing per USP 1231
- Performs plate reads and incubations
- Performs stock culture maintenance and Gram Staining
- Performs environmental monitoring activity as per the procedure
- Prepares culture medias and performs growth promotion testing on media as per SOPs
- Glassware Washing and General Housekeeping and Disinfection of Lab Area.
- Maintaining laboratory inventory
- Monitor/perform internal verification of pH meter, analytical balance, incubators, thermometers, autoclave, refrigerators, Biological Safety Cabinet, etc.
- Keeps current with FDA, ISO, EU and cGMP standards and industry trends
- Maintain and improve lab documents and record keeping procedures
- Handling of Biohazard
- Ensure the interpretation of the data is correct and the results are effectively communicated to appropriate groups
- Prepares, updates or assists in the revision of SOPs, training documentation and departmental forms to reflect current laboratory practices
- Writing/conducting investigations when necessary
- Cross-trains to ensure full functionality on all laboratory equipment and methods
- Trains other employees in the microbiology techniques, SOPs, GMPs, administrative and safety procedures in the laboratory as required.
- Saturday hours to support manufacturing
- Bachelors Degree in Microbiology, Biochemistry, Biology or related disciplines is required
- Three years or more in a cGMP laboratory or manufacturing environment, with two years or more in a cGMP Quality organization is helpful but not required
- Must have GMP and Quality knowledge
- Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management with clarity and accuracy
- Must be skilled in time management.