QC Microbiology Analyst

Duties: Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases. Perform environmental monitoring of cleanroom suites and laboratory areas as required. Perform QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results (for In-Process, Drug Substance, Drug Product, and Stability samples) in support of manufacturing operations. Support routine QC operations, including but not limited to: instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc. Manage inventory of reagents and supplies for the laboratory. Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays. Implement corrective actions and preventive actions (CAPAs). Participate in facility qualification activities for microbiological testing and environmental monitoring. Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time. Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation. Undertake any other duties as required. Skills: Minimum of 2 years of working experience in an FDA-regulated biotechnology or pharmaceutical company. 5 years of experience preferred with no higher education. Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc. Familiar with USP/EP and cGMP/EU GMP regulations. Familiar with instrument and equipment validation. Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Credible and confident communicator (written and verbal) at all levels. Education: Bachelor's Degree or above in Microbiology, Biology or Biotechnology related scientific discipline.