QC Micro Analyst
6 Months CTP
· Performs routine Environmental and Utility Monitoring and testing as needed
· Supports execution of Environmental and Utility qualification protocols as needed
· Performs routine QC Microbiology testing including, but not limited to: Bioburden, Endotoxin, TOC, Growth Promotion, Biological Indicators, Plate Reading, and Microbial Identification
· Authors and Revises SOPs/Forms and other relevant controlled documentation
· Performs peer review of both internal and externally generated data
· Documents environmental, utility, and product excursion investigations (Alert, Action, and OOS)
· Assist with the design, development and implementation of quality control microbiology training programs and training other employees.
· Participates in laboratory equipment qualification activities, as needed
· Participates in verification/validation of microbiological methods (bioburden, endotoxin, etc.), as needed
· Ensures laboratory operational readiness and assist with troubleshooting/continuous improvement as needed.
· Bachelor’ s degree in life sciences, engineering, or equivalent
· Minimum 2-5 years of experience in the biotech industry
· Hands on experience in environmentally controlled areas
· Experience with data review and presenting results to functional management.
· Experience creating/revising/reviewing microbiological SOPs, technical documents, protocols, and investigations.