Environmental Monitoring Technician
Job ID :
US - Kansas - Lenexa
- Weekly, Monthly, Quarterly APR, MPR, and Tubes Environmental Monitoring (Cleanroom batch related sampling is performed by Production)
- Weekly APR Pre and Post Cleaning Environmental Monitoring
- Maintaining stock of media required for routine environmental monitoring program
- Reading and reporting of all Environmental Monitoring and Water Testing plates
- Gram stains, subcultures, and Vitek identifications to support Environmental Monitoring and Water testing
- Generating EM investigation reports for out of limit results
- Data Entry of all Environmental Monitoring results
- Data entry for PIDs in the WIV database
- Filing of EM worksheets and PIDs
- Executing EM Qualification of new manufacturing areas
- Setting of Environmental Monitoring Limits
- Trainer for Gowning (testing, documentation, and results)
- Assists in maintaining standards in accordance with GMP's/SOP's and ISO regulations.
- Sample finished products in accordance to the AQL for specialized products.
- Evaluate effectiveness of 100% inspection process through random AQL sampling of completed inspections.
- Complete MLA testing of products.
- Perform Quanti-Cult testing.
- Support all company policies.
- Performs other duties as assigned.
- Possess at least a high school education. A 4 year degree in the sciences or Course work in microbiology is a plus.
- Possess a minimum combined 2 – 5 years of experience in Quality Assurance, production work, or an equivalent combination of education and experience.
- Familiarity with FDA regulations for medical devices.
- Possess the ability to manage many tasks and in an organized fashion.
- Possess the ability to work in a fast paced environment.
- Possess intermediate computer skills, preferably with experience in Word, Excel, Access, and LIMS programs.
- Listen to, and follow, written and verbal instructions in English.
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