Risk Management Quality Assurance

UYI ENOSIN BELLO

Aberdeen, MD 443-***-**** ********@*****.***

QUALITY ASSURANCE SPECIALIST REGULATORY COMPLIANCE RISK MANAGEMENT

Aspiring Cybersecurity and Quality Specialist with a strong background in risk management, regulatory compliance, and process improvement. Currently transitioning into cybersecurity, leveraging expertise in analyzing, implementing, and optimizing security policies to ensure adherence to industry regulations. Proficient in utilizing enterprise systems such as Jira, SAP, Dayforce, Financial Force, Box, and MasterControl to streamline operations and enhance efficiency. I am skilled in risk assessment, corrective and preventive actions (CAPA), planned and unplanned deviations and regulatory compliance with FDA, ISO, and GMP standards. Passionate about learning and applying cybersecurity principles to safeguard sensitive data, mitigate security threats, and contribute to a secure digital environment.

CORE COMPETENCIES

Quality Assurance & Risk Management

Regulatory & GxP Compliance

CAPA & Audit Management

Computerized System Validation (CSV, CSA)

FDA, ISO, & GMP Compliance

Process Optimization & SOP Development

Quality Management Review (QMR)

Data Integrity & Lifecycle Management

Deviations

PROFESSIONAL EXPERIENCE

Signant Health – Remote (Europe/USA)

Quality Specialist (June 2023 – Present)

Conduct independent quality review and approval of CSV documentation for GxP-regulated systems.

Support CAPA investigations, internal/external audits, and Quality Management Reviews (QMRs).

Analyze compliance risks and escalate quality events or deviations as required.

Ensure adherence to GMP, FDA (21 CFR Part 11), and ISO 9001 regulatory standards.

Provide compliance training and subject matter expertise to cross-functional teams.

BD – Becton Dickinson – Sparks, MD

Quality Systems Specialist II (July 2020 – June 2023)

Led customer audit coordination, ensuring compliance with regulatory and corporate quality standards.

Managed batch history records, tracked corrective actions, and facilitated regulatory documentation reviews.

Supported USDA documentation preparation and compliance tracking.

Partnered with Marketing, Field Sales, and Quality teams to enhance regulatory compliance initiatives.

Service Quality Specialist (Contractor) (July 2019 – June 2020)

Ensured compliance with FDA, GMP, ISO 13485, and 21 CFR Parts 210, 211.

Conducted customer complaint investigations, non-conformance assessments, and root cause analyses.

Developed and revised Standard Operating Procedures (SOPs) for Technical Service & Contact Center operations.

Implemented compliance metrics, decision trees, and escalation protocols to strengthen regulatory oversight.

EDUCATION

Master of Science in Cybersecurity (Expected June 2025)

Minor in IT Management

Southern New Hampshire University (SNHU) – Manchester, NH

Bachelor of Science in Biology (May 2014)

Morgan State University – Baltimore, MD

CERTIFICATIONS & SKILLS

Proficient in quality management software, risk assessment tools, and compliance tracking systems

Strong analytical, problem-solving, and regulatory reporting skills

Excellent cross-functional collaboration and training abilities

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