Quality Control Microbiologist - GroupA : Job Details

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.