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Stephanie Contratto
Senior Consultant @Sequence Inc
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WORK HISTORY
Senior Consultant @Sequence Inc
Responsible for drafting and execution of CQV documents to include Validation Plan (VP), User Requirements Specifications (URS), Risk Readiness Assessments (RRA), Installation/Operation Qualification (IOQ), Performance Qualification (PQ), and Validation Summary Reports (VSR)Analytical Instrument Qualification (AIQ) for systems such as Densitometer, Osmometer, Endotoxin Readers, Milli-Q Purification, Turbidimeter, MiniCapt Viable Cell Counters, Filter Integrity Testers, and Residual Seal Force TesterExecution of Temperature Mapping for Controlled Temperature Units (CTUs) Adherence to regulatory compliance, 21 CFR parts 210, 211, and 11, and standards set by FDA, ICH, USP, and ISOAbidance to data integrity standards as set by ICH, GAMP5, and 21 CFR part 11
EDUCATION
East Carolina University
Master of Business Administration - MBA, Business Administration and Management, General
Western Michigan University
Bachelors, English/Creative Writing
ABOUT STEPHANIE CONTRATTO
A dynamic and results-driven leader with expertise in employee and project management, coupled with a strong passion for human resources. Skilled in fostering effective communication, conflict resolution, and strategic leadership to drive organizational success. Experienced in workforce planning, talent alignment, delegation, and budget management, ensuring operational efficiency. Proficient in CRM, HRIS, payroll systems, and cloud-based platforms to streamline HR and business processes. Active SHRM member possessing SHRM-CP, December 2018-present.
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