Ashley Nicole Weber
New Port Richey,Florida
Summary
Quality leader with 15 years in clinical microbiology and pharmaceutical compounding. Developed and scaled quality systems for multi-facility pharmacy operations. Managed regulatory inspections, CAPA systems, and complaint handling, while enhancing compliance and fostering high-performing teams focused on patient safety and operational growth.
Overview
2027
2027
years of professional experience
1
1
Certification
Work History
Quality Manager
Belmar Pharma Solutions
Odessa, Florida
2023 - Current
- Acted as lead quality authority during FDA, NABP, and state inspections, maintaining regulatory compliance.
- Led investigations for complaints, deviations, and environmental excursions with root cause analysis and CAPA implementation.
- Developed enterprise quality systems for complaint management and structured training across multiple facilities.
- Oversaw and mentored quality personnel across additional facilities, fostering a culture of quality and regulatory adherence.
- Expanded the quality department from one microbiologist to a multi-level team of six technicians and management supervision.
- Conducted quality risk assessments and continuous improvement initiatives for sterile and non-sterile compounding operations.
- Managed environmental monitoring programs for ISO-classified cleanroom environments.
- Authored and maintained SOPs governing quality systems, compounding practices, and compliance programs.
Quality Specialist / Microbiology Lead
Belmar Pharma Solutions
Odessa, Florida
2021 - 2023
- Managed environmental monitoring programs for ISO-classified cleanroom suites, ensuring compliance with industry standards.
- Coordinated sterility testing and reviewed results per USP standards.
- Performed investigations and implemented CAPA for quality events and deviations.
- Developed and revised SOPs, improving compounding quality systems and supporting consistent operational excellence.
- Maintained regulatory documentation, facilitating successful inspections and adherence to regulatory requirements.
Clinical Microbiology Technologist
Cincinnati Children’s Hospital Medical Center
Cincinnati, Ohio
2009 - 2020
- Performed diagnostic microbiology testing in bacteriology, mycology, parasitology, and molecular methods to support accurate patient diagnoses.
- Executed quality control and proficiency testing to maintain compliance with regulatory standards and uphold laboratory integrity.
- Trained laboratory personnel in microbiology disciplines to improve technical skills and ensure high-quality testing.
- Analyzed pathogen surveillance data and trends in antimicrobial resistance.
- Contributed to clinical trials assessing new laboratory methodologies.
Education
Bachelor of Arts - Microbiology
Miami University
Oxford, OHSkills
- Quality management systems (QMS)
- Inspection readiness and regulatory response
- SOP development and governance
- Risk assessment and quality metrics
- Audit management
- Cross-facility quality oversight
- Training and competency programs
- Environmental monitoring programs
- Team leadership and development
Certification
- Technologist in Microbiology (M)CM – ASCP
- Florida Licensed Microbiology Technologist
- Registered Pharmacy Technician – Florida Board of Pharmacy
- Lean Six Sigma Yellow Belt
Timeline
Quality Manager
Belmar Pharma Solutions
2023 - Current
Quality Specialist / Microbiology Lead
Belmar Pharma Solutions
2021 - 2023
Clinical Microbiology Technologist
Cincinnati Children’s Hospital Medical Center
2009 - 2020
Bachelor of Arts - Microbiology
Miami University