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Quality Control Microbiologist

GroupA
Hopewell, NJ Full Time
POSTED ON 1/13/2025
AVAILABLE BEFORE 4/9/2025

Job Type : Contract / 40 hrs week

Location : Hopewell, NJ Onsite

Duration : until 07 / 20 / 2025, with the opportunity to extend further / convert to FTE based on performance / budget

Benefits : Medical, Dental, Vision, Life Insurance

Join our innovative team as a QC Microbiology Analyst and play a crucial role in ensuring our manufacturing operations run smoothly by performing essential microbiological testing and environmental monitoring.

  • Conduct utilities sampling for Water for Injection, Purified Water, Clean Steam, and Process gases.
  • Perform environmental monitoring of cleanroom suites and laboratories.
  • Carry out QC Microbiology laboratory tests, including bioburden, endotoxin, sterility, and microbial ID testing.
  • Support QC operations with instrument qualification, SOP updates, and record-keeping.
  • Manage laboratory inventory and conduct laboratory investigations.
  • Implement CAPAs and participate in method transfer and validation activities.
  • Gown into cleanrooms with varying classifications for extended periods.

Core Skills

  • Minimum 3 years' experience in FDA-regulated biotech or pharma
  • Proficient in microbiological testing methods and familiar with USP / EP and cGMP / EU GMP regulations.
  • Experienced in instrument and equipment validation.
  • Strong communicator, capable of explaining complex concepts at all levels.
  • Education

  • Bachelor's Degree or higher in Microbiology, Biology, or related field.
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