The Microbiologist II is responsible for all duties related to performing environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. The Microbiologist I is also responsible for performing all the microbiological testing related to raw materials, utilities, and in-process product testing. Other responsibilities include data entry, data review, ensuring calibration of equipment, maintaining inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order.

**The schedule for this position will be from 5: 00PM - 3: 30AM.**

Level 1
- Environmental Monitoring Completion
- Utilities completion
- Microbial Identification, enumeration, subculture, Gram-stain, ID entry, VITEK MS
- Raw Material Testing including APIs
- Review
- Growth Promotion
Level 2
- Minimum 2 years of Pharmaceutical EM and Microbiology laboratory
- Endotoxin Testing
- Particulate Testing
- Assist with Special Projects

Responsibilities:

• Responsible for performing all microbiological testing of raw materials, utilities, and in-process, and final products/stability (as applicable) for commercial and method development.
• Responsible (as applicable) for assisting with special projects.
• Responsible for performing daily, weekly, semi-weekly, and monthly environmental monitoring of the manufacturing environment and other areas.
• Responsible for reading plates and enumeration of organisms.
• Responsible for performing organism identification including culturing, isolating, entry, and maintaining of organisms.
• Document and review of raw and final data to ensure complete and proper documentation according to TRC’s procedures and applicable cGMPs.
• Notify Microbiology Laboratory management immediately of out of specification (OOS) results.
• Responsible for routine maintenance and preventative maintenance of laboratory equipment.
• Notify Microbiology Laboratory management of laboratory equipment problems or calibration issues.
• Responsible for reviewing and entering microbiological data into finished product batch records and other applicable laboratory documents (i.e. laboratory notebooks).
• Responsible for assisting with investigations for environmental monitoring excursions (action/alert level investigations), deviations, and OOS results as requested by the Microbiology Laboratory management.
• Responsible for the general maintenance and cleaning of the Microbiology Laboratory (including identification and warehouse areas) including good housekeeping and a safe working environment.
• Responsible for maintaining and entering microbiological data (including Identification) into the Quality database and ensuring all data has been entered by review.
• Responsible for temperature monitoring, maintenance, and notification of calibration of laboratory equipment with some troubleshooting.
• Assist in regulatory audits as requested by the Microbiology Laboratory Manager.
• Assist in training of new employees on all applicable SOPs and tasks.
• Responsible for performing the necessary preparation and testing needed for the maintenance of TRC’s Microbial Culture Collection (HMCC).
• Responsible for assisting with ordering and maintaining inventory of laboratory supplies.
• With guidance from Microbiology Laboratory management, responsible for assisting in review of SOPs.
• Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.