Job Description

Responsibilities:

  • Perform microbiological testing including bioburden, endotoxin (kinetic turbidimetric & gel clot), particulate matter, and 14-day sterility testing in accordance with USP and internal SOPs.
  • Conduct environmental monitoring in classified cleanroom environments (viable/non-viable air sampling, surface sampling, personnel monitoring).
  • Perform facility water system and clean steam sampling, including microbial and endotoxin testing.
  • Enter, review, and trend laboratory data within LIMS; identify atypical results and escalate as needed.
  • Conduct OOS, OOT, and deviation investigations; support root cause analysis and documentation.
  • Assist with CAPA implementation and continuous improvement initiatives.
  • Support cleaning validation, process validation, and special microbiological studies.
  • Maintain laboratory equipment including autoclaves, glassware washers, particle counters, and isolator systems.
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