Senior Clinical Quality Assurance Specialist / GCP Auditor - ICON ISS – Functional Service Provider to Sponsor - New Jersey, USA
(2025-02 - 2025-08)
- Led 8+ GCP site, vendor and system audits across global Phase II and III clinical trials in oncology and infectious disease, ensuring compliance with ICH E6(R2), 21 CFR Parts 11, 50, 54, 56, and 312 and resulting in zero critical findings across sponsor audits.
- Spearheaded process development initiatives to standardize GCP audit planning, execution, reporting and CAPA follow-up workflows.
- Supported inspection readiness for 2+ sponsor programs by executing audit simulations, conducting documentation reviews, patients' safety data review, TMF oversight and contributing to successful regulatory inspection outcomes.
- Evaluated 20+ CAPAs, deviations and root cause analyses, verifying remediation effectiveness and closing compliance risks within agreed timelines.
- Assisted with preparation, organization and distribution of study-related documents and maintained regulatory files and electronic systems to ensure records are accurate, complete and audit-ready.
Senior Clinical Quality Assurance Specialist / GCP Auditor - Shionogi Inc. - New Jersey, USA
(2024-03 - 2024-07)
(Contract)
- Conducted GCP compliance oversight for sponsor-led Phase I and II clinical trials, assessing 3+ studies against internal SOPs, FDA regulations and global GCP standards to ensure ongoing inspection readiness.
- Streamlined quality review workflows in Veeva Vault eTMF, aligning processes with the TMF Reference Model and improving documentation completeness.
- Executed vendor qualification activities for 3+ vendors, including audit support, issue tracking and ongoing.
- Supported and reviewed Institutional Review Boards (IRBs) approved documents including renewals and updates.
Senior Clinical Quality Assurance Auditor, GxP/GCP-QA - Cliantha Research - Gujarat, India
(2019-08 - 2023-03)
- Directed 45+ GCP audits (site, vendor and internal system) across Phase I and II clinical trials for global sponsors, ensuring adherence to ICH E6(R2), FDA and EMA requirements.
- Managed the end-to-end audit lifecycle for 40+ studies, from audit planning and execution through CAPA review and effectiveness verification, achieving 100% on-time audit report delivery.
- Strengthened CAPA management processes by implementing structured root cause analysis and effectiveness checks.
- Facilitated 5+ sponsor and regulatory inspections (including FDA and DCGI) through readiness assessments, mock audits and contributing to successful inspection outcomes with no critical findings.
- Reviewed 10+ SOPs, quality plans and compliance frameworks aligned with ICH-GCP, harmonizing global quality standards and mentoring 5+ junior QA staff to strengthen clinical quality culture.
Quality Assurance Auditor, GCP-QA - Sun Pharmaceutical Industries Limited - Gujarat, India
(2017-03 - 2019-08)
- Delivered clinical quality assurance oversight across 10+ ongoing clinical studies, ensuring full compliance with ICH-GCP, guidelines and Indian and U.S. regulatory requirements.
- Carried out 10+ internal audits and vendor assessments, identifying 30+ compliance gaps and driving corrective action plans that improved site performance scores.
- Reviewed clinical trial documentation, deviations and quality events across 10+ active studies, initiating and tracking 20+ CAPAs through closure with 95%+ on-time remediation.
Lic. Pharmacy Assistant / Pharmacy Technician - Walgreens Pharmacy - New Jersey, USA
(2026-04)
- Assisted pharmacists in dispensing prescriptions and maintaining accurate records.
- Managed inventory and ensured compliance with pharmacy procedures.
- Provided excellent customer service while handling confidential patient information.
- Maintained attention to detail in a fast-paced healthcare environment.
Lic. Behavioral Specialist Education Teacher Assistant-3 - Torey J Sabatini, Madison Public School - New Jersey, USA
(2026-02)
- Provided individualized academic and behavioral support to a student throughout the school day.
- Collaborated with teachers, therapists and school staff to implement individualized education plans (IEPs), if applicable.
- Documented student progress and communicated observations to the educational team.
- Assisted with classroom activities while promoting student independence and engagement.
- Maintained confidentiality and ensured a safe, supportive learning environment.
