QA Environmental Monitoring Associate
The QA Environmental Monitoring Associate 2 will support the Environmental Monitoring Program in the GMP Quality organization. The Environmental Monitoring Associate 2 will ensure that all aspects of environmental sampling and testing associated with utilities and classified areas are within established alert and action levels.
Duties and Responsibilities:
* Perform surface, non-viable, viable air, settling plates in the transfer room and isolators
* Perform gowning qualification of all MFG personnel upon exit from Transfer Suite
* Perform compressed gas and water sampling and testing
* Label, track and continuously monitor viable air (SMA. Settling plates) in the isolators and transfer suite
* Incubate and enumerate organisms on cultured media
* Coordinate with manufacturing on scheduling of EM sampling
* Responsible for media inventory. Ensure that the TSA and other related media use for environmental monitoring passed growth promotion testing prior to use
* Ability to read, understand and follow SOPs
* Ability to work in an aseptic environment
* Monitoring of temperatures of incubators and refrigerators
* Track and Trend EM data including Microbial identification results in support for product release
* Write/Revise EM SOPs
* Provide input to technical reports
* Order laboratory supplies as needed.
* Ability to stand for a long period of time
* Ability to lift 20 lbs
* May perform other duties as assigned
* A minimum Bachelor's degree in a scientific discipline is preferred and 4 years of EM experience in a pharmaceutical/biotech industry or sector
* AA with 6 years EM experience in a pharmaceutical/biotech industry
* BS. Degree requires a minimum experience of 4 years performing EM or Microbiology Testing in the pharmaceutical/biotech industry.
* Ability to work independently on departmental projects and initiatives with minimum supervision.
* Strong verbal, written communication skills and computer skills are required.
* Proficiency in Excel is a plus
Sthree US is acting as an Employment Business in relation to this vacancy.