Dave Brown Email & Phone Number

Boulder, Colorado, United States

Batch Disposition, Non Conformance review and approval, Document review and approval

Longmont, Colorado, United States

Manage team dedicated to authoring production deviation investigations at the ACO site

Longmont, Colorado

Business Process Owner for Nonconformance’s, CAPA and Change Control

Boulder, Co

Primary site disposition manager. SME for site training on dispositionHost for FDA site PAI inspectionsResponsibilities:Change ControlsDeviationsCAPAQA Project/Product LeadDocument creation / review / revision (SOP, BPR, Technical Documents, etc)Disposition

Boulder

• Instituted a disposition program including generation of site specific procedures and policies• Disposition Manager for all products produced at the site• QA contact for implementation of Blue Mountain Maintenance Management System Project• QA site lead for client product• Revised Change Control program philosophy to utilize pre and post implementation datesQA contact for the following programs:• Change Controls• Deviations• CAPA• Batch Record Review• Work Orders – Job plan approvals and equipment entries• Document generation, revision and approval (Batch and Solution Production Records, Logs, Validation records (IOQ, PQ), process development Technical Documents, SOP’s, etc) • Project Support• NPI support• Audit support both internal and external• Raw Material and disposable product contact component QA release

Longmont, Colorado

EXPERIENCESENIOR QUALITY SPECIALIST/SUPERVISOR Amgen, Inc. – May 2005 to April 2014• Disposition Manager of Drug Substance packages for products received and stored from other Amgen manufacturing sites (AMG-157, 162, 386, and 479). 79 batches since 2012.• Responsible for the performance and development of 3 batch record review Quality staff• Presented inspection materials to FDA and EMA inspectors, as well as creating and preparing presentation materials and performing data entry for inspections by Anvisa (Brazil), the Turkish Ministry of Health, TGA (Australia) and Johnson and Johnson. • Responsible Quality individual on numerous critical project teams including Electronic Batch Records, MES upgrade, Bulk Risk Mitigation, Unit Operation Report replacement, and Material Re-classification• Site Quality Owner for Process Monitoring and In Process Control programs• Responsible Quality signature on change control records, SOP’s, Batch Records, Validation Protocols, Process Development protocols, deviations and CAPAs• Maintain and communicate departmental metrics to senior leadership and reported to Site Quality Review Team• Leads area and system audits, documents findings and follows up on responses• Operational Excellence training • Lean Initiative experience including Batch Record Redesign – Acted as Quality lead for project that reduced batch record pages by 30%; reducing batch record entry errors by 20%.

Boulder And Longmont Colorado

See Resume

Bachelor'S Degree, Social Sciences

Social Sciences

Social Sciences, History

Activities and Societies: Sigma Nu Fraternity