JOB SUMMARY
Perform microbiological analyses and environmental monitoring to support manufacturing and packaging operations using suitable instrumentation according to cGMPs. Supports laboratory to ensure laboratory procedures equipment supplies and inventory are available for routine testing monitoring and for qualification and implementation of new tests and equipment.
ESSENTIAL FUNCTIONS RESPONSIBILITIES
Sample Testing and Environmental Monitoring
• Perform routine microbiological analyses and reporting of raw materials components sample requests and finished products including but not limited to Microbial Limits.
• Perform environmental monitoring of purified water water for injections clean steam compressed air and non-sterile manufacturing operations.
• Perform duties that support the laboratory function such as media preparation housekeeping and use of autoclaves.
• Perform environmental sampling in advanced aseptic areas. Ability to aseptically gown required.
• Ability to work aseptically in a lab setting as well as aseptic processing area.
• Actively participates in job training.
Laboratory Environment Maintained to GMP Standards
• Prepares media reagents and diluents.
• Provides support for start-up functions including but not limited to balance checks temperature checks calibration checks and remediation of biological wastes.
• Performs laboratory glassware washing.
• Autoclaves utensils reagents media diluents and test equipment Performs laboratory file maintenance.
• Monitors equipment certificationcalibration schedules and schedules associated calibrationcertifications.
Inventory Maintained at Appropriate Levels
• Maintains supply inventory through ordering receipt and rotation of supplies.
• Performs inventory.
Safe Compliant Efficient Labs
• Supports lab systems assigned and maintains laboratory in compliance with SOPs cGMPs HS&E requirements and FDA DEA USP EP CDCNIH and OSHA regulations.