When laboratory operations — microbiology, stability, or electronic data systems — need stronger control, I help establish those functions and review lab data for data-integrity risk.
I saved almost $500K by bringing TOC and conductivity testing in-house, and set up a microbiology laboratory to bring sterility, endotoxin, and residual DNA testing in-house. I also managed the implementation of Empower 3 chromatography software.
I managed analytical R&D, method development, and method validation, and set up a stability testing program per ICH guidelines and a post-submission FDA commitment, while overseeing the receipt, review, and release of raw material, bulk, finished product, and stability samples.
The validation documentation for each laboratory instrument system included system classification, impact and risk assessments, and a data integrity (DI) assessment, alongside URS, traceability matrix, and IOQ protocols and reports.
I have more than ten years of hands-on experience with Empower, LIMS, EZChrom, ChemStation, and Millennium, plus TrackWise, and I am familiar with 21 CFR Part 11 and document control with audit trails.
Laboratory data your quality and regulatory teams can stand behind.