Test Method Validation - Microbiologist

Charlotte, NC

Industry: Pharmaceutical Job Number: 134321

 

Test Method Validation – Microbiologist (Swab Method Validation and Recovery)

 

Environment:

Our client is a large aseptic manufacturing plant. Looking for someone to help conduct Test Method Validations as it relates to Swab Method Recovery.

Duties/Responsibilities/Scope of Work

Ideally this person will have experience Counting colony forming units (CFU) on Petri plates.  Must have experience performing Growth Promotion and inoculum cultures.  This person will also perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.  Must be able to maintain accurate and complete test record as well as instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples. 

Other responsibilities will include but not limited to the conduction of method development, method validation and method transfer. Conduct statistical evaluation of the data. Ensure control of laboratory documentation (Raw Material COA, testing instructions, testing.)

Education:

Required Experience:
  • Bachelor’ s degree in Microbiology, or closely related scientific discipline. 
  • Degree in Microbiology is highly preferred. 
  • Laboratory experience is preferred. 
  • Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience. 
  • Microbiology laboratory skills and knowledge, such as aseptic techniques, is required. 
  • Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
  • Must be able to read, write, and speak English. 

Job Type: Contract 

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