kathleen ortega

chemist

About

Licensed Chemist / QA Supervisor A highly-organized licensed chemist with over 10 years of successful experience in the environmental and pharmaceutical industry. Highly competent in reviewing and approving documentation to assure conformity with domestic and international regulatory requirements. Able to work under strictly demand of compliance in a consent decree environment. Effective in management and organization of personnel. Strong problem-solving and decision making skills with the ability to develop and implement effective action plans. Excellent communication and presentation skills. Bilingual in English and Spanish, good-fellowship, teamwork ability, leadership enforcement, and computer literate in MS Office applications, LIMS, Millenium Data Acquisition System, GEDMS (Documentum) and other computerized systems.

Country

united states

City

athens

Industry

chemicals

Skill

quality management, human factors, cross functional team, chemistry, hplc, gmp, gxp, biotechnology, change control, poe, process improvement, quality assurance, cleaning validation, medical devices, technical writing, analytical chemistry, supervisory skills, quality auditing, business process, customer service, fda gmp, technical support, regulatory submissions, anda, management, project management, quality control, pharmaceutical industry, process management, glp, uv/vis, people skills, capa, fda, sop, 21 cfr part 11, biopharmaceuticals