Microbiologist II - EM/Utilities

About the role

This position performs environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. It includes all microbiological testing related to raw materials, utilities, in-process product testing, and final products/stability for commercial and method development projects.

Responsibilities

• Perform daily, weekly, semi-weekly, and monthly environmental monitoring of the manufacturing environment and other areas.
• Read plates and enumerate organisms; perform organism identification including culturing, isolating, entry, and maintenance of organisms.
• Conduct microbiological testing of raw materials, utilities, in-process, and final products/stability samples.
• Document and review 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.
• Perform routine and preventative maintenance of laboratory equipment; notify management of equipment problems or calibration issues.
• Review and enter microbiological data into finished product batch records and other applicable laboratory documents (e.g., laboratory notebooks).
• Assist with investigations for environmental monitoring excursions (action/alert level investigations), deviations, and OOS results as requested.
• Maintain and clean the Microbiology Laboratory, including identification and warehouse areas, ensuring good housekeeping and a safe working environment.
• Enter microbiological data (including identification) into the Quality database and ensure all data has been reviewed and entered.
• Monitor, maintain, and calibrate laboratory equipment, including troubleshooting as needed.
• Assist in regulatory audits as requested by the Microbiology Laboratory Manager.
• Train new employees on all applicable SOPs and tasks.
• Prepare and test samples for the maintenance of TRC’s Microbial Culture Collection (HMCC).
• Order and maintain inventory of laboratory supplies.
• Assist in the review of SOPs with guidance from Microbiology Laboratory management.
• Follow Standard Operating Procedures, safety, health, and cGMP guidelines.
• Perform endotoxin testing, particulate testing, and assist with special projects.

Requirements

• BS degree in Microbiology or a related field with at least 1 year of pharmaceutical QC Microbiology laboratory experience or equivalent.
• Minimum 2 years of experience in Pharmaceutical Environmental Monitoring (EM) and Microbiology laboratory work.
• Proficiency with current word processing, spreadsheets, and database software.
• Demonstrated knowledge of standard laboratory techniques and procedures.
• Ability to operate standard and advanced laboratory instrumentation.
• Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within QC and across departments.