Quality Control Microbiology Analyst

Job Description:

The ideal candidate will be responsible for performing various laboratory tasks including utilities sampling, environmental monitoring, and QC Microbiology testing.

• Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases.
• Perform environmental monitoring of cleanroom suites and laboratory areas as required.
• Perform QC Microbiology 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) in support of manufacturing operations.
• Support routine QC operations, including but not limited to: instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc.
• Manage inventory of reagents and supplies for the laboratory.
• Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
• Implement corrective actions and preventive actions (CAPAs).
• Participate in facility qualification activities for microbiological testing and environmental monitoring.
• Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time.
• Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
• Undertake any other duties as required.

Requirements:

• Bachelor's Degree or above in Microbiology, Biology or Biotechnology related scientific discipline.
• Minimum of 2 years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
• 5 years of experience preferred with no higher education.
• Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
• Familiar with USP/EP and cGMP/EU GMP regulations.
• Familiar with instrument and equipment validation.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a 'can do' attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.