QC Analyst

Responsibilities

• Perform microbiological testing of water systems, including endotoxin testing using Sievers instrumentation, in accordance with GMP requirements and site procedures.
• Conduct water and product bioburden testing, growth promotion testing, and other routine microbiological analyses supporting manufacturing operations.
• Review, interpret, and document microbiological test results while ensuring data accuracy, integrity, and regulatory compliance.
• Support QC laboratory administrative activities, including creating purchase orders for laboratory supplies.
• Cook up and coordinate testing activities with external laboratories.
• Own and support laboratory investigations, Laboratory Investigation Reports, Nonconformance Reports, and related documentation.
• Train laboratory personnel on microbiological test methods, sample collection, sample submission procedures, and laboratory best practices.

Qualifications

• Bachelor's degree in Microbiology, Biology, Life Sciences, or a related scientific discipline, or an equivalent combination of education and laboratory experience.
• Professional microbiology testing experience within a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Hands-on experience with water endotoxin testing using Sievers equipment.
• Experience with water and product bioburden testing and growth promotion testing.
• Experience reviewing microbiological data, supporting laboratory investigations, and maintaining GMP-compliant documentation.
• Strong organizational, communication, and training skills.
• Ability to manage multiple priorities and work effectively with internal teams and external laboratories.