Nicholas Lemister

I’m a GMP/GLP metrology and Lab Instrument Services leader with 14 years in the pharmaceutical industry, including 7 years focused on GMP/GLP metrology work. I work across ICH and FDA expectations, with deep experience in calibration methodologies, requirements, tolerances, and loop calibrations.

I’ve led calibration and qualification efforts for critical analytical and manufacturing equipment, performing and supporting installations, performance maintenance, troubleshooting, and IQ/OQ/PQ validation. I also drive quality outcomes through investigations and documentation—OOT/OOS, deviations, failures, and CAPAs—along with strong technical writing for reports, SOPs, validations, and mappings.

Across my roles (including LIS Supervisor, Metrology Engineer, and Laboratory Service leadership), I’ve maintained CMMS systems, improved workflow and performance metrics, and partnered with interdisciplinary teams to keep sites operational. I mentor and coach teams, manage vendor and contractor execution, and ensure clean-room/CLIA environments meet GXP and FDA requirements.