Monica Arango

Background

About Monica Arango

Analytical Manager with over 20 years experience in pharmaceutical, chemical and consumer health manufacturing industry. Experience with laboratory auditing, SOP and protocol writing and reviewing, Change Control, instrument qualification, training, safety, and consent decree. Certified Quality Auditor, trained in 49CFR/IATA for the shipment of hazardous materials, trained in hazardous waste management. Extensive interactions with domestic and international customers and vendors, instrument contractors, CROs, maintenance & engineering, QA and Regulatory groups. Analytical mindset, oriented towards creative problem solving and assessing the validity of processes. Excellent communication, leadership, presentation, and negotiation skills. Conversant in Supply Management, Scheduling and Planning, Resource Planning. Specialties: HPLC • GC • GCMS • LCMS• ICP • TLC • IR • NMR • UV • DSC • TGA • KF • TOC • WET CHEMISTRY • TRAINING • EMPOWER • TOTALCHROM • GC SOLUTIONS • EAMS • MAXIMO • PDOCS • PLS• GXPHARMA • MS WORD • EXCEL • CONTINUOUS PROCESS IMPROVEMENT • AUDITING • CHANGE CONTROL • CONSENT DECREE REGULATORY COMPLIANCE PROTOCOLS: FDA, cGxP (cGMP, GLP), SOPs