Execute daily environmental sampling for dynamic or static environmental monitoring (EM) of cleanrooms.
Perform incubation, enumeration and gram staining of microbiological organisms.
Perform growth promotion testing for media release.
Document and maintain required QC records and logs.
Trend and analyze EM data.
Report and participate in the investigation of EM excursions, deviations, out-of-specification results, etc.
Perform preparation and shipment of EM related samples to external contract testing laboratories when necessary.
Write technical documents such as reports, change controls, and SOPs.
Perform visual inspections and release testing on materials as needed.
Other duties as assigned.
Qualifications and Requirements :
Bachelor of science in a Life Sciences or related discipline.
2-5 years of relevant experience working in a Quality Control work environment, preferably in a regulated environment in the pharmaceutical / biotech industry.
Working knowledge of cGMP regulations.
Experience working and gowning in a cleanroom environment.
Aseptic behaviors training
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