Rita O.
Senior Quality Assurance Specialist at Sdc Statistics & Data Corporation
Based in Phoenix, United States
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Seniority
Staff
Department
Information Technology
Location
Phoenix
Industry
Biotechnology Research
Company size
156
Contact information
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r•••••••@sdcclinical.com
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Background
About Rita O.
Experienced Quality Assurance & Regulatory Compliance Leader with expertise in Clinical Data Management, GxP, CSV, and Process Improvement I am a results-driven Senior Quality Assurance Specialist with a strong background in regulatory compliance, clinical trials, pharmaceutical/biotech and clinical quality management. With over five years of experience ensuring compliance with FDA, EMA, Health Canada, MHRA, ICH, ISO, and cGMP standards, I specialize in: Clinical Data Management (CDM) & eTMF Systems – Veeva, iMednet, Medidata Regulatory Compliance & Audits – GCP, GxP, FDA, EMA, ICH, ISO 13485 CAPA, Risk Management & Process Validation – Root Cause Analysis, CAPA Implementation Computer System Validation (CSV) & SDLC – Ensuring regulatory adherence for digital systems I am passionate about optimizing quality processes, leading cross-functional teams, and improving data integrity to drive operational excellence. Let’s connect to discuss opportunities in clinical quality, regulatory compliance, and data management.
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