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Job ID :
46241BR
Location :
US - Kansas - Lenexa
:
Job Description

Key Responsibilities:

  • 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.

Minimum Requirements/Qualifications:

  • 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.




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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