2019-PresentQuality Assurance Contractor, Oceanside, CA (Cancer Immunotherapy Company)Provide Quality Assurance support for the Implementation of the Viral Vector Manufacturing Facility• Support Implementation Site Training Function• Create Raw Material and Process Material Specifications• Create/Revise procedures as needed• Perform Batch Record Review and support Lot Disposition• Manage Sequoia QA Staff2019Quality Consultant, San Diego, CA (Biotech Company Specializing in Biosimilars)Provided support for the development, implementation and maintenance of GxP quality systems and activities• Managed Document Control and acted as subject-matter-expert (SME) • Trained EDMS end users and provided technical support• Maintained paper-based and electronic Quality Systems • Maintained employee training records• Participated in the evaluation of the Quality System and processes for optimization • Managed Sequoia Consultant staff 2017-2019Quality Consultant, San Diego (Large Genomics Company)Provided Quality Compliance support to Equipment Engineering.• Inspected equipment records for gaps in work order alignment and adherence to good documentation practices• Reviewed and approved equipment engineering work instructions and procedures• Tracked and facilitated closure of CAPA records • Managed quality consultant staff 2015-2017 (Large Biotech Company)Site Lead/Senior Technical Writer Oceanside, CACreated, edited, and processed Standard Operating Procedures, Forms and Work Instructions for Maintenance, Facilities, and Supply Chain/Distribution. Maintain standardized and consistent documentation practices.

Implement and maintain systems and procedures to ensure and enhance overall quality focusing on Document Control, Deviations, GMP training, Change Control, Quality System and Corrective and Preventative Action (CAPA).

Manage the implementation and active management of Amylin’s GXP Quality Systems. Site subject matter expert for TrackWise workflow activities. Review and approve Deviations, CAPAs, Effectiveness Checks, and Change Control Records. Manage the Approved Supplier List. Partner with other functional areas to resolve quality issues. Author, review and approve SOPs. Provide support for regulatory inspections.Generate and present Quality System metrics for Quality Leadership, Management Reviews and Annual Reports. Develop department training curriculum. Defend departmental procedures and practices to internal and external auditors

2005 - 2007Performed product release of clinical packaged product to support of domestic and international clinical trials. Review and approve manufacturing procedures and clinical product label artwork.2003-2005Developed and maintained training curricula for Quality Assurance and Site Supply Chain. Deliver new hire and refresher GMP Compliance Training.2002 - 2003Managed the Product Disposition Quality System; facilitated continuous improvement.2000 - 2002Managed the Thousand Oaks’ Microbiology Monitoring Program. Facilitate continuous improvement; benchmarked microbial monitoring industry practices; facilitate bi-weekly QA/QC issues to discuss and resolve issues.1998 -2000Managed Microbiological Monitoring Program for a multi-product clinical and commercial manufacturing facility; developed and maintained environmental and bioburden Monitoring programs; reviewed and approved Standard Operating Procedures, validation documents, work orders, alert/action notifications, manufacturing procedures, microbiology certificates, and microbial trend investigation report; supervised daily operations of QA Microbiology Staff1994 - 1998Quality Assurance support for maintenance (sanitary utilities) and microbiological monitoring supporting GMP Drug Product and Drug Substance production; coordinated and performed sanitary utilities sampling; Generated alert/action reports, batch record microbiology certificates and microbial investigation reports; audit manufacturing plant and sanitary utilities for compliance to procedures and industry expectations; conduct microbial monitoring adverse trend investigations

Perform routine microbiological monitoring and testing, including Sterility, Bacteriostasis/Fungistasis, Particulate Matter, Bacterial Endotoxin, Antimicrobial Effectiveness Testing, Microbial Identification and Antibiotic Assays on Finished Product.