Senior QC Microbiologist - Subject Matter Expert

About the Job

• Perform sterility, endotoxin, pH and osmolality testing on raw materials, drug substance, and drug product
• Perform gram stains, sub-culturing of isolates, growth promotion testing, and general cell culture
• Coordinate, schedule, and execute testing based on manufacturing schedules
• Direct performance in Aseptic Processing Media Fills and perform support testing, including visual inspection
• Maintain housekeeping and equipment maintenance including organization, cleanliness, and logbooks
• Assist the Quality Control department in daily operations, as needed
• Author and revise QC SOPs and change controls as necessary to maintain compliance
• Author and execute qualification protocols and reports for microbiological assays
• Perform timely response to Out of Specification (OOS) results, including notification to area management. Perform and document laboratory investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrent are considered implemented. Execute associated CAPA.
• Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA++ principles.
• Troubleshoot and analyze nonconforming data. Completion of thorough investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented.
• Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain compliance
• Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule
• Perform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing and particulate monitoring, inside the aseptic clean rooms, as necessary
• Oversight of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed
• Training of other employees as necessary