Job Description

This employee supports the Microbiology and Environmental Monitoring (EM) department in implementing and managing the site’s microbiology and EM programs as well as the overall microbiology laboratory operations to ensure compliance with current regulations. This position requires direct interaction with the manufacturing processes related to biological non-sterile drug substance and sterile drug product. The employee’s qualification in aseptic gown is required.  

Essential Duties & Responsibilities 

• Performs environmental monitoring of TPI-controlled and aseptic manufacturing areas. 
• Collects samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles. 
• Incubates viable samples. 
• Streaks and sends representative EM isolates to contract laboratory for identification. Receives results and performs data entry for trend analysis.  
• Complies with annual gowning qualification. 
• Performs sanitation and temperature verification of laboratory refrigerators and incubators. 
• Performs routine monitoring for water for injection (WFI), reverse osmosis (RO), purifies water (PW), and clean steam (CS) systems. 
• Submits samples for testing to microbiology laboratory or contracted laboratory for TOC, conductivity, microbial count, and endotoxins. 
• Performs routine monitoring of compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, oil, and moisture. 
• Performs bacterial endotoxin testing of WFI, CS, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples. 
• Performs gram stain and growth promotion tests. 
• Performs tests for bioburden and microbial limit. 
• Performs visual inspection of microbiological, EM samples and media fill units. 
• Performs data entry of results in Excel for trend analysis. 
• Reviews microbiology laboratory data. 
• Generates OOS or Out of EM Action/Alert Levels Notification, when required. 
• Lead laboratory investigations and/or support manufacturing investigations, when required. 
• Generate Change Controls for Equipment/Instruments qualifications, Process or Document Changes. 
• Lead procedures, methods or specifications revisions acting as Contributor using Master Control System. 
• Other tasks as requested by management.