Nick Nowak

I am a highly skilled and experienced microbiologist with a strong background in the pharmaceutical and gene therapy industries. I am committed to delivering exceptional scientific support and analysis while ensuring compliance with regulatory guidelines.

Experienced microbiology and quality control leader with a progressive track record from Laboratory Aide to Quality Control Manager. Over 6 years of experience in sterile pharmaceutical manufacturing environments, with deep expertise in microbiological testing, regulatory compliance, and team leadership. Proven ability to implement efficient QC systems, lead investigations, validate in-house testing methods, and drive continuous improvement across QC operations.

Key Highlights:

Led and developed QC microbiology teams, managing scheduling, training, and performance.

Extensive experience in sterility testing, environmental and personnel monitoring, mycoplasma PCR, endotoxin, and rapid microbial detection methods.

Strong command of FDA, EU, ICH, and cGMP regulatory guidelines and quality systems.

Conducted complex investigations and implemented CAPAs to resolve non-conformities and improve processes.

Authored and revised SOPs, managed documentation and sample logistics, and ensured readiness for audits.

Delivered detailed environmental monitoring trend reports and enhanced laboratory safety and productivity.

Hands-on leadership in ISO 7 cleanroom environments, with frequent cross-functional collaboration to support R&D and manufacturing operations.

Bachelor of Science in Biomedical Sciences from Sam Houston State University, 2013-2017.