Mariama Barry

Background

About Mariama Barry

A dedicated Regulatory Affairs Specialist with more than ten years of advanced experience in Contract Development Manufacturing Organization in CGMP environment producing clinical grade product, knowledge of cell culture, biotech/pharmaceutical manufacturing processes, and maintaining of clean room environments. Highly motivated and goal oriented skilled Cell & Gene Therapy Technician, Quality Records Specialist in the areas of investigating Deviations, Environmental Excursion Notice (EEN), Root Cause Investigations, Technical Writing, Critical Thinking, Data Analysis and Data Trending. Bringing a proven track record of measurable improvements in regulatory and quality compliance. The ability to design, oversee, and enforce regulatory and quality management systems in order to establish and maintain organizational compliance standards. The ability to develop, train, and ensure compliance to regulations including CGMP, US FDA regulations (21 CFR 210,211,610), FDA Guidance, and ICH Guidelines. Excellent time management skills, outstanding administrative skills, outstanding communication skills, problem solving skills, well organized and detailed oriented. Over 15 years in Retail Sales, Customer Service, and Marketing. Leading a Quality Regional Customer Service Team. Developed annual customer service training for all employees training requirements. Provided training for all regional customer service managers. Acted as a liaison to promote satisfaction by meeting customer requirements and resolving any concerns and issues, managed and addressed customer complaints.