Melissa joined CREO with over 10 years of experience in the life-sciences industry and a strong background in laboratory analysis, regulatory compliance, and computer systems validation. She has comprehensive experience in Data Integrity, Part 11/Annex 11, SDLC, and GAMP-based CSV.
Melissa’s role prior to joining CREO was Global CSV Manager with Catalent where she defined validation strategies of computer systems, provided oversite of global CSV efforts, refined CSV policies and procedures, performed internal IT/CSV/DI site audits, responded to client and regulatory audits, performed system periodic reviews, and oversaw validation components of IT change control, investigations, deviations and CAPAs.
Melissa also has prior experience in Global IT Quality providing quality oversight of CSV, DI and IT QMS including IT change control, system periodic reviews, deviations, investigations and CAPAs.
Melissa earned her Bachelor of Science in Chemistry and her Master of Applied Science in Forensic Investigations from Missouri Western State University.
