Torrance Lee
Fremont,CA
Summary
Experienced GLP Quality Assurance auditor and archivist dedicated to ensuring compliance through collaboration. Seeking opportunities to drive continuous improvement and positively impact the cell and gene therapy space by ensuring reliable and integrity of nonclinical data.
Overview
27
27
years of professional experience
Work History
Associate Manager, Research Quality Assurance
Astellas Pharma Inc.
03.2023 - Current
- Engaged in cross functional teams with a focus on increasing awareness of quality matters and offering insights into improving the organization's culture, systems, and processes to achieve enhanced compliance.
- Assist the stakeholders with mitigation activities by ensuring that corrective actions are appropriate and effective.
- Author or revise research quality assurance unit SOPs to address gaps or to enhance the current workflows.
- Review functional SOPs from a quality and compliance perspective.
- Maintained a comprehensive system for record-keeping of completed nonclinical study materials according to SOPs and the GLP regulations.
- Ensure that the archive system allows for orderly storage and expedient retrieval of all records.
Research Quality Assurance Specialist
Astellas Pharma Inc.
07.2021 - 03.2022
- Maintain quality assurance records relating to audit activities.
- Support the QAU's general auditing needs, including scheduling pre-audit and audit-debrief meetings, distributing audit reports, and tracking audits.
- Advise study personnel, study monitors, sponsor representative, and management on quality-related issues.
- Conduct or facilitate internal and external facility inspections to assure management that the facility meets GLP and/or internal quality standards.
- Effectively communicate quality and compliance findings, along with recommended corrective actions, to management, study directors, personnel, sponsor representatives, and study monitors.
- Archive and manage submitted internal nonclinical materials, including electronic records, in accordance with 21 CFR Part 58, Standard Operating Procedures, and internal policies.
- In collaboration with the nonclinical functional groups, monitor the transfer of materials from the service providers to third-party archive.
- Coordinate requests, transfers, and retrieval of materials from offsite or internal archives.
- Revise and develop archive SOPs (and forms) to ensure archival activities comply with regulatory requirements.
GLP Archivist
Bayside Solutions (Contract)
South San Francisco , CA
02.2021 - 07.2021
- Developed and maintained the nonclinical archive indexing system and database for physical records.
- Collaborated with consultants to customize an electronic repository for archiving electronic data
- Worked closely with stakeholders to determine the archival locations of nonclinical study records.
- Managed the indexing and maintenance of final report and protocol records in the electronic repository.
Senior Formulations Scientist
Valent U.S.A. LLC
06.2020 - 02.2021
- Ensure that QC laboratories are ready and capable of accurately running analytical methods.
- Provide analytical standards, cross-evaluation samples, and test methods prior to each production campaign.
- Review the results from the analysis of the cross-evaluations to ensure acceptable agreement with internal values.
- Inform responsible parties of QC laboratory readiness.
- Work with QC lab personnel and Analytical Staff to resolve analytical issues.
- Receive QC test results during and at the completion of each production campaign, and maintain this information in a QC database.
- Review the QC data for completeness, to look for trends, and to spot potential quality problems or concerns.
- Respond to internal requests for information about product lots and QC data.
- Ship QC cross-evaluation samples, retains, and field samples in accordance with DOT and IATA regulations.
Quality Assurance Specialist III
Valent U.S.A. LLC
11.2012 - 06.2020
- Review Protocols, Methods, and Standard Operating Procedures for conformance to GLP standards.
- Conduct in-process, raw data, and final report audits to ensure internal, industry, and GLP standards are fulfilled while meeting critical deadlines.
- Advise study personnel, study monitors, and management on GLP-related issues.
- Coordinate, direct, and monitor contract Quality Assurance consultants to perform timely GLP inspections in accordance with internal quality standards.
- Assist in the establishment of policies and procedures to ensure compliance with GLP standards for Valent QA operations.
- Conduct or facilitate internal and external facility inspections to assure management that the facility meets GLP and internal quality standards.
- Effectively communicate to management, study director, personnel, and/or study monitor of GLP findings or recommendations.
- Administer or facilitate the new hire orientation and the annual refresher GLP training.
Quality Assurance Specialist II/GLP Archivist
Valent U.S.A. LLC
11.2007 - 11.2012
- Assist with all QA activities, including in-process, raw data, and final report audits.
- Assist in establishing policies and procedures to ensure compliance with GLP standards for Valent QA operations.
- Manage the GLP archive to ensure all records are stored and indexed in a manner that allows for expedient retrieval.
- Responsible for managing the Valent SOP program.
- Conduct inspections at contract research laboratories.
Associate Scientist
Valent U.S.A. LLC
09.1997 - 11.2007
- Conduct complex environmental fate and metabolism studies under EPA GLPs with minimal supervision.
- Use radiolabeled test substances to determine the disposition and rate of degradation in a variety of complex matrices, including animal and plant tissues, and soil and water.
- Performed field residue studies to quantitate analytes in the low parts per billion range.
- Isolate and purify unknown metabolites for structural elucidation by LC-MS (ESI and/or APCI)
- Process, summarize, and evaluate raw data to determine the follow-up steps to be taken in order to satisfy requirements as outlined by the study protocol and by EPA guidelines.
- Modify and adapt methods to overcome sample matrix interferences that result in poor recoveries or affect sample analysis.
Education
BS - Environmental Toxicology
University of California, Davis
01.1997
Skills
- Research Quality Assurance auditor
- Archivist
- Compliance
- Cross functional teams
- Good Laboratory Practices (EPA-FIFRA and FDA)
- Audit activities
- Internal and external facility inspections
- Standard Operating Procedures
- Contract research laboratories
- Microsoft Excel/SharePoint/Word
- Veeva Vault
Timeline
Associate Manager, Research Quality Assurance
Astellas Pharma Inc.
03.2023 - Current
Research Quality Assurance Specialist
Astellas Pharma Inc.
07.2021 - 03.2022
GLP Archivist
Bayside Solutions (Contract)
02.2021 - 07.2021
Senior Formulations Scientist
Valent U.S.A. LLC
06.2020 - 02.2021
Quality Assurance Specialist III
Valent U.S.A. LLC
11.2012 - 06.2020
Quality Assurance Specialist II/GLP Archivist
Valent U.S.A. LLC
11.2007 - 11.2012
Associate Scientist
Valent U.S.A. LLC
09.1997 - 11.2007
BS - Environmental Toxicology
University of California, Davis
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