Ruth Espinoza Email and Phone Number

With over 13 years of regulatory and quality assurance experience within various manufacturing environments, I am a highly-motivated and resourceful team player. My professional experience encompasses:Quality Assurance: Development of Quality Management Systems, to include; complaint management, deviation management, corrective and preventive action, change control, training, and document control. Policy and procedure development. Gap/risk assessment. Recalls and complaint handling. Audit to determine Good Manufacturing Practices compliance with applicable regulations, guidelines, procedures, policies, quality systems, and vendors.Regulatory Affairs: Compile regulatory documents, and information for Site Master File document submissions for Plasma Master File (PMF) to fractionators, facility registration and adverse event reporting to the Food and Drug Administration.Validation: Develop Standard Operating Procedures (SOP), validation protocols (IQ, OQ, PQ), and Validation Master Plans (VMPs). Create and execute validation test scripts, and write validation reports for computer systems/software and equipment.Training: Established training programs, as well as, coordinating employee training. Prepared/presented training lectures to groups of up to 220 people covering such topics as Deviation Management, Standard Operating Procedures, Safety Programs and Policies. I demonstrate leadership, team development and project management skills which further enhance my professional experience, facilitate completing assigned projects, and meeting overall Company objectives. I have an excellent work ethic and proven ability to work in a diverse and fast-paced environment. My ability to work in English and Spanish adds to my versatility.