About Raquel Hand, B.S., CQA, CTBS

Senior Quality Specialist | Lead Auditor | Life Sciences Compliance Expert

📍 San Diego, CA   |   📧 raquelrhand@gmail.com   |   ☎️ 858.210.9057

I am an ASQ Certified Quality Auditor (CQA) and Certified Tissue Bank Specialist (CTBS) with over seven years of experience ensuring compliance and quality excellence in the tissue banking, pharmaceutical, and medical device industries. My focus is on maintaining regulatory compliance, leading audits, and fostering continuous improvement across complex quality systems.

Experience Highlights

  • Lead GMP and QMS audits nationwide for FDA and ISO-regulated companies.
  • Implemented risk-based supplier audit programs reducing travel and cost.
  • Hosted multiple successful FDA and third-party inspections with zero 483s.
  • Achieved AATB reaccreditation and supported international product launches (HTA, TGA, Health Canada).

Core Skills

  • Quality Auditing (CQA, CTBS, AATB)
  • FDA & ISO Compliance
  • Supplier/Vendor Management
  • Document & Training Systems (Veeva, MasterControl, eLM)
  • CAPA & Deviation Management
  • Technical Writing & SOP Development
  • Continuous Improvement
  • Operational Excellence

Education & Certifications

B.S. in Biology, Columbus State University, GA
ASQ Certified Quality Auditor (CQA)
Certified Tissue Bank Specialist (CTBS)

Audit History Summary

Over the course of my auditing career, I have successfully conducted 25+ GMP and QMS audits across the United States, evaluating suppliers, vendors, and service providers that support the tissue banking, pharmaceutical, biologics, and medical device sectors. My audit experience includes a diverse range of facilities, from sterile manufacturing environments to analytical labs and logistics providers.

Types of Companies Audited

  • Tissue Banks – AATB/FDA accredited organizations, including DCI Donor Services, Solvita Tissue Bank, LifeLink, and PTT.
  • Manufacturers of Primary Containers & Packaging – Berry Global, Gerresheimer Glass, SCHOTT Pharma.
  • Pharmaceutical & Biologics Organizations – FUJIFILM Irvine Scientific, Biologos, Calbiotech, Isto Biologics-related suppliers.
  • Contract Testing & Analytical Laboratories – Nelson Labs, WUXI AppTec, DDL, providing microbiological, material, and analytical testing.
  • Sterilization Service Providers – Sterigenics (Gamma, EO, E-beam, and X-ray sterilization).
  • Calibration & Equipment Service Companies – Micro Precision, pipette.com.
  • Cleanroom & Environmental Monitoring Services – Azzur Group, Pegasus Cleanroom Services.
  • Logistics & Cold Chain Transport Providers – QuickSTAT (temperature-controlled and regulatory logistics).
  • Regulatory & Medical Oversight Entities – Michael J. Bauer & Associates (medical director audit scope).

These audits covered a broad range of industry standards and regulations including FDA 21 CFR Parts 1271, 210/211, and 820, as well as ISO 9001, ISO 13485, and ISO 17025. Through these engagements, I have strengthened supplier relationships, verified compliance, and identified opportunities for continuous quality improvement across the life sciences supply chain.