Demo

QC Microbiology Analyst

Planet Pharma
Pennington, NJ Full Time
POSTED ON 3/16/2025
AVAILABLE BEFORE 4/9/2025

6-month initial contract

Hopewell, NJ

  • 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.
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