Maria Isabel Melendez
About Maria Isabel Melendez
Maria Isabel Melendez is the Associate Director of IT Quality Management - Problem Management at Bristol Myers Squibb in Tampa, Florida.
Current Position at Bristol Myers Squibb
Maria Isabel Melendez works as the Associate Director of IT Quality Management - Problem Management at Bristol Myers Squibb. She is based in Tampa, Florida, United States. Her responsibilities likely involve overseeing IT quality and problem management processes to ensure compliance and efficiency within the company's IT operations.
Career at Bristol Myers Squibb
Maria has held multiple positions at Bristol Myers Squibb, beginning as a QA Computer Systems Administrator, progressing to various roles including IT Quality Assurance R&D, IT Quality Management, and Senior Manager of Problem Management. Her experience spans from IT quality management to leading initiatives for Latino achievement and representation within the company.
Employment History
Before joining Bristol Myers Squibb, Maria worked in numerous roles across different companies. She served as a Senior Validation Scientist at Ultimate Solutions, a Senior Validation Engineer at Validation & Engineering Group, and a Senior Consultant at JC Automation and cGMP Group, among others. Her extensive career history includes positions in computer systems validation, laboratory analysis, and educational consulting.
Education and Certifications
Maria holds a Master of Science and a Bachelor in Science in Analytical Chemistry from the University of Puerto Rico-Mayaguez. She is certified in multiple regulations pertinent to health authorities including GxP, 21 CFR Part 11, and Annex 11. Her academic background and certifications underscore her expertise in analytical chemistry, quality control, and compliance.
Technical Skills and Expertise
Maria has extensive experience in Consent Decree remediation, CAPA, and Change Control. She specializes in Computer System Validation (CSV), equipment qualification for laboratory, manufacturing, and packaging processes. Her skill set includes generating Standard Operating Procedures (SOPs), conducting audits, and expertise in QC Laboratory Automation. Additionally, she is proficient in Failure Mode and Effect Analysis (FMEA) and Continuous Manufacturing Process, along with aseptic process and QC method transfer and validation.