Microbiologist II

About the role

This position performs environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. It also 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.
• Conduct microbiological testing of raw materials, utilities, in-process, and final products/stability samples.
• Document and review raw and final data to ensure compliance with 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; report equipment problems or calibration issues.
• Review and enter microbiological data into finished product batch records and other laboratory documents (e.g., laboratory notebooks).
• Assist with investigations for environmental monitoring excursions, deviations, and OOS results as requested.
• Maintain and clean the Microbiology Laboratory, including good housekeeping and a safe working environment.
• Enter microbiological data (including identification) into the Quality database and ensure all data is 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 applicable SOPs and tasks.
• Maintain TRC’s Microbial Culture Collection (HMCC) through necessary preparation and testing.
• Assist with ordering and maintaining inventory of laboratory supplies.
• Assist in the review of SOPs under 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.
• 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 work in a team-oriented environment and develop positive working relationships within QC and across departments.