Environmental Monitoring Specialist
6 days ago
- Responsibilities:
- Perform Quality Control Microbiological testing of environmental monitoring sampling and microbiological testing in accordance with cGMP/FDA regulations, RLT standard operating procedures and Policies.
- Perform environmental monitoring in aseptic, classified, and controlled areas.
- Perform growth promotion, bioburden and biological indicators testing.
- Enumerate organisms on cultured media for environmental monitoring and utility samples.
- Review of routine paperwork.
- Direct support of the manufacturing schedule.
- Requirements:
- Entry level Bachelor's degree required with 0-2 years experience.
- 1+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.
- Demonstrated ability in performing environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and analysis.
- Previous experience with Laboratory IT systems such as LIMs.
- Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
- Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.
- Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
- Due to the nature of the process (radioactive) this role requires moderate proficiency, of the basic quality control techniques, EM instrumentation, aseptic technique, and understanding of radiation safety standards.
- Understanding of GMP and GDP highly preferred.
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