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Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs Lab work and other tasks as assigned by management.
Job Responsibility:
Perform routine Environmental Monitoring of the classified clean rooms
Monitor classified clean rooms during manufacturing operations, must gown qualify
Sample and test the Water for Injection System, USP Purified Water systems and Clean Steam systems
perform and document plate reads for all environmental and utility testing with minimal supervision
Write and execute protocols/experiments/SOPs under limited supervision
Reviews work of peers and SOP document changes under limited supervision
May assist senior staff in preparation of investigations, reports and execution of complex protocols
Visual inspection of media fill vials and plates
Perform general lab maintenance/housekeeping
Training of staff in routine processes
Requirements:
High School Diploma required
BS/BA degree in Microbiology or related scientific field preferred
3-5 years’ experience in a cGMP environment
Detail oriented
Ability to multi-task
Ability to gown to work in an ISO-5 environment
Ability to work varied hours as required by the production schedule