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Job Duties:
- Provide a variety of analytical functions that occur in the QC environmental monitoring and utilities monitoring laboratory.
- Perform hands-on environmental monitoring and utilities sampling, testing, and reporting, supporting oral dose and cell therapy GMP manufacturing facilities.
- Experience in a GMP laboratory setting, preferably in microbiology or environmental monitoring.
- Understand of US and EU cGMP regulations have some flexibility to work off hours if necessary. Responsible for quality control associate to take on more.
- Check microbial contamination by performing bioburden and endotoxin testing on WFI samples using aseptic technique.
- Select by senior leadership to supervise and manage team of analysts and provide training on environmental monitoring.
- Collect water for injection (WFI) and clean steam samples from (ISO) 5, 7, and 8 classified areas.
- Observe microbial growth through sterility, coli testing, gram staining, plate read, and growth promotion.
- Engage in interviewing prospective hires and played a key role in the onboarding process for new employees.
- Perform lab support functions and inventory management.
- Clean controlled temperature units, operation of the autoclave and other basic lab support responsibilities.
Education: The minimum qualification required for the performance of the above specialty occupation duties is a bachelor's degree or equivalent in Computer Science or equivalent in a related field or a foreign equivalent is required closely related field with relevant experience.