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Toca Beauty

@tocabeauty

Senior GxP Quality Assurance Auditor at Pfizer, leading risk-based audits and strengthening compliance across global research programs.

United States

Message

At Pfizer Inc, I serve as a Senior Manager, GCP/GLP Auditor and conduct risk-based audits across CROs, clinical sites, and internal labs. I also oversee root cause analysis and CAPA management and support GLP study packages submitted to the FDA.

Earlier, at HJF Medical Research International - Defence Reference Laboratory (DRL), I developed a QMS that led to ISO 15189 accreditation and mentored laboratories toward ISO 15189/CAP accreditation. My work has also included quality assurance for HIV research programs, clinical laboratory compliance, and inspection readiness.

Experience

Work history, roles, and key accomplishments

Current

Senior Manager, GCP/GLP Auditor

Current

Pfizer Inc

Sep 2023 - Present (3 years 1 month)

Primary GxP auditor for 30+ CROs, clinical sites, and internal labs, maintaining 100% compliance. Executed 70+ risk-based audits annually, achieving 98% on-time completion and 100% on-budget delivery.

GCP GLP GxP Auditing Risk Based Audit CAPA Root Cause Analysis Training FDA Submissions

Quality Assurance Specialist, GLP

Technical Resources International

Jun 2021 - Sep 2023 (2 years 3 months)

Supported QMS for 20+ NIH/government contracts and conducted 50+ GCP/GLP/GMP audits. Evaluated 60+ laboratory SOPs for regulatory compliance and inspection readiness.

QMS GCP GLP GMP Audit SOP Review Document Control Inspection Readiness

Clinic Associate

Omega Family Clinic

Apr 2019 - May 2021 (2 years 1 month)

Coordinated lab requests, POCT, and sample management for all patients. Processed 600+ SARS-CoV-2 PCR specimens and ensured weekly turnaround compliance.

POCT sample management PCR laboratory operations

Quality Assurance Manager

HJF Medical Research International

Feb 2016 - Dec 2018 (2 years 10 months)

Developed QMS leading to ISO 15189 accreditation of DRL and mentored 25 laboratories toward ISO 15189/CAP accreditation. Conducted 50+ GCP/GLP audits and oversaw 10 internal audit cycles.

QMS ISO 15189 CAP GCP GLP Audit Training HIV Research

Senior Program Specialist

HJF Medical Research International

Jan 2013 - Jan 2016 (3 years)

Coordinated enrollment, data management, and shipment for 50,000+ aliquots. Conducted 40+ GCP/GLP audits and supported clinical trial safety testing.

Data Management GCP GLP Audit Clinical Trials Laboratory Testing

Assistant Laboratory Officer

HIFASS

Oct 2010 - Dec 2012 (2 years 2 months)

Managed confidential records for 5,000 volunteers and conducted POCT and waived testing for 3,000 participants. Oversaw 1,000+ controlled documents and supported GCP/GMP audits.

POCT Records Management Document Control GCP GMP Audit