Yasmeen Hamami, Cmq/Oe Email & Phone Number

New York, United States

Jamaica, New York, United States

Under the Office of Regulatory Affairs (ORA), currently overseeing and managing the Consumer Safety Quality Assurance Program for Human and Animal Foods East Division 1 (HAFE1). Transitioned from the co-located New York Laboratories (NYLHAF/NYLMP) to jump straight into developing proactive Quality measures for handling Powdered Infant Formula Consumer Complaints and CAPAs. Supported NYLHAF/NYLMP through end of calendar year 2023 to ensure 2024 accreditation renewal application was submitted accordingly.Recently promoted to Project Manager for the Consumer Safety Quality Metrics and Analytical Dashboard that I co-developed, troubleshooted, and improved.

Jamaica, New York, United States

Under the Office of Regulatory Affairs (ORA), oversaw and managed the Quality Assurance Program for New York Human and Animal Food (NYHAF) and Medical Products Laboratories (NYMP). Authorized Representative responsible for holding Certificate of Accreditation IAW ISO 17025:2017.Notable Accomplishment(s):-Supervised and mentored Quality Assurance Intern for 10 weeks. Project was 100% QMS Audit to identify redundant, obsolete, and/or erroneous documents in a system of 550 documents. Outcome was 18% reduction in QMS in 10 weeks’ time.-Secured 2022 and 2024 ISO 17025:2017 and AOAC (2018) Accreditation for the Laboratory.-Established a new internal chemical/reagent re-qualification program that has not been previously established at any other field laboratories.-Involved 60% of Laboratory staff with the CAB renewal application and persuaded several to voluntarily join the Quality Team as co-auditors during a cross-functional internal audit of applicable work products, processes, and services.-Single-handedly increased the number of internal audits conducted since FY20 by 1200%.-Increased Quality Assurance Program workload by 50% since FY21.-Introduced 8 internal Quality Assurance training courses in FY22.-Harmonized internal Quality Management System documents across Food, Feed, and Drug Chemistry and Microbiology despite differing regulatory requirements.

New York, New York

Adhered to rigorous requirements in monitoring all aspects of GMP activities for investigational CAR-Ts, Abs, cancer vaccines, gene therapies, and radiolabeled and organic NMEs for 14 internal manufacturing laboratories/facilities and 7 external companies, a total of 21 independent clients. Engaged in comprehensive inspection of GLP facility and review of preclinical study final reports to confirm compliance with GLP QMS/21 CFR 58. Demonstrated strong client management abilities.Notable Accomplishment(s): Selected to advise clinical protocol team on illuminating agent product classification with fast-track approval/NDA once IND cleared for clinical trials. Contributed to CMC for 3 other INDs.

Brooklyn, Ny

Expertly conducted 70% of all deviation investigations. Implemented CAPAs and executed all CAPA effectiveness verifications. Managed changes to SOPs and QC processes (microbiology assays, specifications, and validated methods). Co-facilitated companywide meetings to meet timelines and targets in completing compliance documentation.Notable Accomplishment(s): Bridged QA/RA gap at Cresilon by working closely with RA Associate to develop regulatory processes for advertising and promotional material review, labeling design, US recall program, and complaints. Used technical acumen to provide RA oversight to support preclinical R&D during final stages of IFU approval for veterinary device.

Brooklyn, New York

Employed expertise to write and review QA deviation investigations, CAPAs, and CRs. Demonstrated technical acumen in revising veterinary device QMS SOPs and Quality Manual (ISO 13485). Held accountability for the organization’s quality database, document control, and training systems. Volunteered to act as the QA representative for QC during tenure; took initiative to address a gap in compliance functions for QC.

Brooklyn, New York

Gained rich experience while engaging in a wide range of QA functions. Worked collaboratively with team members across the department to execute QA assignments.Notable Accomplishment: Developed a fully functional, companywide SharePoint-based QA recordkeeping system quality database that tracked thousands of QMS records in just 6 weeks in the role.

Stony Brook, New York

Master Of Science (M.S.), Regulatory Affairs For Drugs, Biologics, And Medical Devices

Bachelor Of Science, B.S., Biochemistry

Minor in Writing and Rhetoric