What are the responsibilities and job description for the Microbiologist position at Ivory Systems?
Job Title: QC Microbiology Analyst
Key Responsibilities:
- Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases.
- Conduct environmental monitoring of cleanroom suites and laboratory areas as required.
- Undertake microbiological laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results (for In-Process, Drug Substance, Drug Product, and Stability samples).
- Support routine operations, including instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival.
- Manage inventory of reagents and supplies for the laboratory.
- Investigate laboratory anomalies, deviations, and invalid assays.
- Implement corrective actions and preventive actions.
Requirements:
- A minimum of 2 years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
- Experience with 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.
- Credible communication skills and strong analytical ability.
- Able to prioritize tasks, work accurately in a demanding environment and use own initiative.
Education:
Bachelor's Degree or above in Microbiology, Biology or Biotechnology related scientific discipline.
