Quality Control Manager - Certified Laboratories - Tustin, California
(2022-07 - 2026-03)
Managed Microbiology, Biochemistry, Wet Chemistry, HPTLC, and GC/GC-MS laboratories, overseeing daily operations and ensuring compliance with quality and regulatory standards.
- Reviewed and approved analytical data, ensuring accuracy, integrity, and compliance with SOPs and GMP requirements.
- Led authoring and review of Out-of-Specification (OOS) and deviation investigations, including root cause analysis and implementation of corrective and preventive actions (CAPA).
- Coordinated daily testing schedules to align with project timelines and ensure timely release of laboratory reports.
- Served as a technical point of contact for clients, addressing analytical data and method-related inquiries.
- Supported Quality Assurance during internal and ISO audits, ensuring audit readiness and timely resolution of findings.
- Trained, interviewed, and onboarded new laboratory personnel, strengthening team capability and performance.
- Troubleshot laboratory, testing, and instrumentation issues, minimizing downtime and improving efficiency.
- Provided regular updates on laboratory performance and metrics to senior management, facilitating informed strategic decision-making.
Chemistry Technical Specialist - Certified Laboratories - Tustin, California
(2022-05 - 2022-07)
Media Manufacturing Quality Control Manager - Phenomenex, Inc. - Torrance, California
(2021-12 - 2022-04)
Managed quality control testing for media manufacturing, ensuring timely release of silica and media to support production schedules.
- Reviewed non-conformance reports (NCRs) and out-of-specification (OOS) results, verifying effectiveness of corrective and preventive actions (CAPA) to ensure compliance.
- Collaborated with R&D and cross-functional teams to investigate root causes of NCRs and OOS events, enhancing quality assurance processes.
- Assisted Quality Assurance with internal and ISO audits.
- Conducted Gemba walks to monitor laboratory operations and identify opportunities for continuous improvement, fostering a culture of quality.
Quality Control Supervisor - Kova International, Inc. - Garden Grove, California
(2020-04 - 2021-12)
- Test finished product and bulk samples of clinical urinalysis controls.
- Test raw materials used in manufacturing of clinical urinalysis controls.
- Trained new analysts, filed complaints, wrote non-conformance and deviation reports, and reviewed QC paperwork, batch records, and manufacturing documentation.
- Scheduled daily QC tasks and developed new SOPs and lab protocols to enhance operational consistency.
- Maintain all QC urine analyzers.
- Review clinical urinalysis controls labels and final control kits prior to shipping.
- Conducted research and development projects to innovate and improve clinical urinalysis controls.
- Assist with MDSAP audit and internal audits.
Regulatory Affairs Manager - Med Pharmex Inc. - Pomona, California
(2018-08 - 2020-02)
- Prepared and submitted regulatory filings, including Annual Drug Experience Reports, Minor Stability Changes Reports, JINAD submissions, CBE-0, CBE-30, and PAS.
- Coordinated Adverse Event reporting and product recall submissions to FDA, ensuring compliance with regulatory requirements.
- Supported FDA inspections, customer audits, and authored responses to Form 483 observations.
- Updated and maintained Veterinary Master Files (VMF) to ensure current and accurate regulatory documentation.
- Authored and revised SOPs, process validation protocols, and pilot batch records.
- Authored OOS and deviation reports for quality control laboratory data.
- Conducted OOT stability investigations.
- Reviewed batch records for accuracy and compliance with GMP standards, supporting quality assurance initiatives.
Regulatory Affairs Specialist - Med Pharmex Inc. - Pomona, California
(2016-07 - 2018-08)
Associate Supervisor QC Chemistry - Med Pharmex Inc. - Pomona, California
(2015-02 - 2016-07)
QC Lead Chemist - Med Pharmex Inc. - Pomona, California
(2005-06 - 2015-02)
Ensure quality and purity of raw materials, finished products and stability for leading distributor of high quality generic veterinary medicines.
- Test finished products and stability samples using USP and in-house methods and perform USP and manufacturer's impurities testing on raw materials.
- Test verification of compendial methods.
- Test manufacturer's raw material impurities methods.
- Operate and troubleshoot HPLC /UPLC.
- Developed and documented new lab test procedures and standard operating procedures to ensure compliance and consistency.
- Collaborated on special projects that streamlined lab processes and improved overall efficiency.
- Trained new chemists on lab equipment and procedures, facilitating their onboarding and integration into the team.
QC Chemist II - International Medications Systems, Ltd. - South El Monte, California
(2004-08 - 2005-06)
QC Chemist I - International Medications Systems, Ltd. - South El Monte, California
(2003-01 - 2004-08)
Tested raw materials, finished products, and stability samples of sterile, injectable pharmaceuticals to ensure quality and compliance with industry standards.
- Conducted testing of Water for Injection for total organic carbon and heavy metals to verify safety and purity.
- Conducted tests on raw materials to determine melting points and identify substances.
- Performed titrations, standardized volumetric solutions, and additional testing to ensure compliance.
- Prepared Certificates of Analysis for raw materials and finished pharmaceutical products to document compliance with regulatory requirements.
- Ensure regulatory compliance by learning USP, BP, EP and JP Methods.
Chemist I - Watson Labs - Corona, California
(2002-08 - 2002-12)
- Prepared assay, content uniformity, and chromatographic purity samples of tablets to ensure compliance with USP and FDA regulations.
- Studied and adhered to Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) in the laboratory environment.
- Operated HPLC and UV-VIS spectrometers for accurate analysis of chemical compounds.
