What are the responsibilities and job description for the Senior Microbiologist position at GroupA?
Job Summary
We are seeking a highly skilled Senior Microbiologist to join our team at GroupA. As a key member of our quality control laboratory, you will be responsible for ensuring the highest standards of quality and safety in our products.
- Responsibilities
- Perform sampling of Water for Injection, Purified Water, Clean Steam, and Process gases.
- Conduct monitoring of cleanroom suites and laboratory areas to maintain optimal standards.
- Execute laboratory testing, including bioburden, endotoxin, sterility, and microbial ID testing.
- S Support daily operations such as instrument qualification and maintenance, SOP generation and revision, specification updates, record keeping, and archival.
- Oversee the inventory of reagents and supplies for the laboratory.
- Conduct investigations, including OOS, Out of Trend, deviations, and invalid assays, and implement corrective and preventive actions (CAPAs).
- Participate in qualification activities for microbiological testing and environmental monitoring.
- Engage in method transfer and validation activities, including protocol preparation, execution, and report writing.
Requirements
- Minimum of 2 years of experience in an FDA-regulated biotechnology or pharmaceutical company.
- Expertise in microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
- Familiarity with USP/EP and cGMP/EU GMP regulations.
- Proficiency in instrument and equipment validation.
- Analytical and Problem-Solving Abilities: Strong analytical skills and a hands-on approach with a 'can do' attitude.
