Experience

Self Product Management / Strategy

Quality Systems Specialist

8/2020 - Present

Process Improvement/ CAPA/ Supply Chain / Manufacturing / Quality System Remediation/ Startup / Troubleshooting / Multi-Site / International / Six Sigma / Validation / Team Building
Wide range of experience and success in QA/QC within diverse manufacturing environments for Fortune 500 medical device and pharmaceutical firms.

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Gilead Sciences Management Consulting

Auditor

6/2022 - 7/2022

GILEAD, La Verne and San Dimas, CA April 2022 – July 2022
SOP GMP gap assessment for Gilead Engineering Department.
● Reviewed 80+ SOPs for initiating, executing, and closing work orders for equipment calibrations for routine calibrations and out of tolerance conditions, new equipment qualifications, and utility maintenance.
● Recommended revisions for engineering change and pest control SOPs, in alignment with 21 CFR Parts 110 & 111.

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ABZENA Finance

Auditor

2/2022 - 3/2022

GMP audit of biologic facility and evaluated facilities, utilities, material management, temperature control of finished products, manufacturing, equipment qualifications, Validation Master Plans, deviation and CAPAs Prepared comprehensive, fact based, audit reports, allowing operations to accurately address the root causes of non-conformances and the subsequent development of effective corrective actions plans.

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Catalent Management Consulting

Tech Writer

5/2021 - 9/2021

Conducted and led Quality Management Deviations/ CAPAs for biotechnology manufacturers. Lead CAPA team meetings and prepared necessary documentation.

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Baxter International Management Consulting

Deviation Infestgator

10/2020 - 4/2021

Executed validation protocols (IQ, OQ, and PQ) for installation and qualification of new equipment and software for a new form, fill and seal machine. Prepared deviation, corrective action, and final reports for validation protocols. Reviewed revised design specifications for correcting software issues, identified during protocol execution.

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GSK Management Consulting

GMP auditor

4/2020 - 8/2020

Performed quality review of OTC batch record reviewers who performed batch record remediation of OTC pharmaceutical product manufacturers. Mentored and coached manufacturing persona for correction of batch records and deviation investigations to resolve product quality issues.

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PharmaBioServe Corporate Strategy & Development

Sr. Process Quality Consultant

4/2020 - 8/2020

Quality Lead for 6 batch record reviewers that performed batch record remediation of over the counter pharmaceutical product pharmaceutical manufacturer. Developed the batch record review protocol, checklist and remediation trending data used to review over 650 batch records. Identified critical quality issues identified with executed batch records. Provided coaching for manufacturing and batch record reviewers to help resolve quality issues.

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Apathecus Management Consulting

GMP Battch Record Auditor

1/2020 - 4/2020

Delivered quality oversight for FDA Warning Letter response commitments and drafted a summary report of batch record review. Reviewed results and provided guidance for deviation investigations and CAPAs. Created new SOP for manufacturing deviation investigations. Investigated manufacturing paper data integrity issues

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Hemp Extractions Management Consulting

Tech Writer

4/2019 - 12/2019

Performed a GMP review for facility engineering drawings for two new CBD oil facilities.
● Reviewed equipment installation, qualification plans, material, personnel flow, and engineering drawings against FDA 21 CFR, Subpart C Building and Facility regulations for HVAC, Purified Water, and OFCA.

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Teva Pharmaceutical Management Consulting

Deviaition Investigator

4/2019 - 8/2019

Prepared deviation and CAPA reports related to utility, facility, equipment, and tablet processing using the TrackWise Quality Management Software. Provided timely updates of work planning, work in progress, and summaries of work completed.