Scientist III, QC Micro

Description

Scientist III, QC Micro is responsible for managing the Microbiology staff and laboratory. Create, review and revise SOPs related to testing and sampling. Organize and schedule Microbiology activities. Represent QC Microbiology in production meetings and other meetings as required. Participate in audits, if necessary. 

Requirements

• Supervised the Microbiology Laboratory and staff.
• Ensure competent performance of microbiology personnel.
• Create or revise departmental SOPs.
• Manage verification of USP compendia] methods related microbiology by writing verification protocols, execution of the protocols and authoring the reports.
• Maintain the quarterly report for the Microbiology lab tracking all Alerts, Actions, or OS.
• Maintain the quarterly EM trending of GMP areas, HPW reports and QC lab monitoring.
• Perform all relevant microbiology tests and reports.
• Review and approve all micro test results.
• Maintain, review, and approve all equipment logbooks associated with the Microbiology Lab.
• Coordinate in-house and outside testing.
• Keep Microbiology area in a tidy, always organized and in a sanitary condition.
• Create, execute, and compile qualification/validation protocols and reports related to Microbiology.
• Write deviations, investigations, OS and change control reports.
• Conduct training for new recruits and company-wide on topics pertaining to microbiology and aseptic technique.
• Uses NetSuite in ordering/inventory of lab supplies.
• Works with communicating and supporting all departments. 1 7. Communicate with outside venders and contractors.
• Monitor USP compendia and other standards to ensure procedures and processes are current with industry standards.
• Monitor Manual vial filling and Machine Filling operations for Media and product filling.
• Supervise Vial Visual Inspection. 

Education and Experience Required:

• Master's degree in Microbiology, Biology, or related scientific field.
• Minimum 7 years of hands-on QC Microbiology experience in a GMP-regulated environment, with prior leadership or team lead experience strongly preferred.
• Proven proficiency in microbiological testing including bioburden, endotoxin (LAL), sterility testing, environmental monitoring, water testing, microbial identification, and growth promotion testing.
• Experience with deviations, OOS/OOT investigations, CAPAs, change controls, and SOP authorship/revision.