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GroupA

Quality Control Microbiologist

GroupA, Hopewell, New Jersey, United States


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.