QC Analyst (Endotoxin Testing)

At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a QC Analyst: Endotoxin Testing.

Position Type:

• Contract
• Onsite

Required

• Bachelor's degree in Microbiology, Biology, Life Sciences, or a related scientific discipline, or equivalent combination of education and relevant laboratory experience.
• Prior professional experience performing microbiological testing in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Hands-on experience with water endotoxin testing using Sievers equipment and water/product bioburden testing, including growth promotion testing.
• Experience reviewing microbiological data, supporting laboratory investigations, and maintaining documentation in accordance with GMP and data integrity requirements.
• Strong organizational, communication, and training skills with the ability to manage multiple priorities while collaborating effectively with internal teams and external testing laboratories.

Responsibilities:

• Perform microbiological testing of water systems, including endotoxin analysis using Sievers instrumentation, in compliance with GMP and site procedures.
• Conduct water and product bioburden testing, including growth promotion testing and other routine microbiological analyses to support manufacturing operations.
• Review, interpret, and document test results, ensuring data accuracy, integrity, and compliance with applicable quality and regulatory requirements.
• Support QC laboratory operations by managing administrative responsibilities, including purchase order creation for laboratory supplies, coordinating testing with external laboratories, and owning laboratory investigations (LIRs), nonconformance reports (NCRs), and related documentation.
• Train laboratory personnel on microbiological testing methods, sample collection and submission procedures, and laboratory best practices to maintain consistent and compliant testing activities.