Drucila O'Zwoldike
Midlothian,VA
Summary
Experienced Auditor focused on improving business compliance, workflow and processes through detailed audits and optimization recommendations. Successful track record of fully evaluating information, structures and procedures and initiating corrective actions.
Overview
6
6
years of professional experience
Work History
Auditor I
PPD, Part Of Thermo Fisher Scientific
07.2020 - Current
- Conduct comprehensive audits of laboratory data of up to 50 Multiplex Opsonophagocytic Assay (MOPA), ELISpot, and microneutralization assay projects to ensure compliance with client methods, regional regulations, and standard operating procedures
- Implement training and mentor new quality assurance junior and senior staff, including cross-training of inter-departmental staff to ensure consistent quality standards
- Streamlined workflow processes for staff of up to 60 individuals, such as managing daily priorities, creating Microsoft Teams channels for subgroups, and leading department meetings
- Perform annual internal audits and inspections of three laboratory buildings to evaluate compliance with established quality assurance process, standards, global regulatory guidelines, and client contractual obligations
Assistant/Associate Scientist
Pharmaceutical Product Development LLC
01.2018 - 07.2020
- Conducted over 220 routine to complex sample preparation and analysis procedures for the Multiplex Opsonophagocytic Assay (MOPA) testing the efficacy of various vaccines
- Reviewed calculations and results and compared data for quality control against SOP acceptance criteria, methodology, protocol, and product specifications
- Trained on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and applicable Title 21 CFR and CLIA regulatory guidelines.
- Point of contact for Scheduling Team which oversaw and coordinated 50+ analysts' schedules
Education
Bachelor of Science - Biology
Virginia Commonwealth University
Richmond, VA12.2017
Skills
- Internal Auditing
- Root Cause Analysis
- Corrective and Preventative Actions (CAPA)
- Microsoft Office
- Clear Communication
Timeline
Auditor I
PPD, Part Of Thermo Fisher Scientific
07.2020 - Current
Assistant/Associate Scientist
Pharmaceutical Product Development LLC
01.2018 - 07.2020
Bachelor of Science - Biology
Virginia Commonwealth University