Jonathan Leffler
South San Francisco,CA
Summary
Senior Quality Assurance Specialist with 15+ years in biopharmaceuticals, focusing on operational excellence and process improvements. Demonstrated success in enhancing manufacturing processes and implementing robust Quality Management Systems (QMS). Strong mechanical aptitude supported by extensive hands-on experience in adapting to evolving industry standards.
Overview
21
21
years of professional experience
Work History
Senior Quality Assurance Specialist
Alector
South San Francisco, CA
10.2022 - 03.2025
- Executed lot disposition and release of Investigational Medicinal Product for clinical studies in United States and Canada, ensuring compliance with internal procedures and international regulations.
- Completed the review of executed batch records for Drug Substance and Drug Product manufactured at sites in the United States, Europe, and Asia, and collaborated with QPs to enable the release of products (IMP) for use in clinical studies abroad. Assessed external manufacturing non-conformances, deviations, and investigations, managing deviation records in Alector electronic Quality Management System (Veeva).
- Facilitated weekly virtual meetings with contract manufacturers across United States and Europe to address quality and inventory concerns.
- Managed document and change control processes, serving as the primary contact for inter-organizational document management within Veeva.
- Supported audits of Alector quality systems conducted by business partners to ensure adherence to standards.
Quality Assurance Associate II
Vaxart
South San Francisco, CA
10.2021 - 09.2022
- Reviewed executed batch records for internal and external manufacturing processes.
- Performed line clearance for Drug Substance and Drug Product manufacturing. Supported internal audits and ensured the facility maintains inspection readiness.
- Performed receiving, inspection, and material release for cGMP production, addressing quality and inventory control issues.
- Identified deficiencies in material management and revised the material part and lot number assignment SOP.
- Revised Good Documentation Practices SOP for alignment with business practices and current industry standards and developed GDP training material.
- Scheduled calibration and preventive maintenance. Updated the equipment files and maintained the equipment log.
Principal / Lead Filling Technician
Genentech, A Member of The Roche Group
02.2004 - 06.2021
- Represented operations in FDA inspections and health authority audits, and interacted with the auditors during the presentation of executed batch production records.
- Ensured that commercial and clinical IND (Investigational New Drug) and IMP (Investigational Medicinal Products) fulfill the specified requirements, and are released according to the approved registration dossiers, in compliance with the regulatory filings.
- Reviewed and approved master batch records, achieving nearly 100% accuracy over five years.
- Participated in cross-functional meetings to manage change controls, and collaborate on GMP documentation.
- Contributed to investigations and CAPAs as an engaged team member.
- Provided expertise to Manufacturing, Process Engineering, Facilities, Validation, QC, and EQA teams.
- Approved Change Records for new product introductions, procedures, equipment modifications, and technology transfers.
Education
GED -
U.C. Santa Barbara
Santa Barbara, CA01-1997
High School Diploma -
Cupertino High School
Cupertino, CA01-1995
Skills
- Veeva QMS and Trackwise DMS
- SAP ERP systems
- FDA, EMA, and ICH regulations
- CFR and GxP compliance
- ISO 13485:2016 Standards
- Change Control and CAPA
Timeline
Senior Quality Assurance Specialist
Alector
10.2022 - 03.2025
Quality Assurance Associate II
Vaxart
10.2021 - 09.2022
Principal / Lead Filling Technician
Genentech, A Member of The Roche Group
02.2004 - 06.2021
GED -
U.C. Santa Barbara
High School Diploma -
Cupertino High School
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