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QA Environmental Monitoring Associate

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

Qualifications:

* 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

Experience:

* 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.