Microbiology Associate Scientist

JOB SUMMARY

Perform microbiological analyses and environmental monitoring to support manufacturing and packaging operations using suitable instrumentation according to cGMP’s. 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 certification/calibration schedules and schedules associated calibration/certifications. 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, CDC/NIH and OSHA regulations.