Alex Valdez
Business Solutions Manager at Edwards Lifesciences
- Role
- Business Solutions Manager at Edwards Lifesciences
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Alex Valdez
Eleven years of management experience over seeing a team of 8 chemist in the Quality Chemistry Lab by providing guidance and schedule planning to execute release testing of release raw materials, in-process, and finished products and authoring both lab investigations and NC reportsTeamed with cross functional team (Planning, Manufacturing, Supplier Quality, Plant Quality) to support the release of release raw materials, in-process, and finished products by scheduling release testing per FIFO and providing input to the cross functional team on schedule constraints and mitigation solutionsPM for Labware LIMS and Empower 3 Lab Software Implementation. Lead a cross functional team (Quality Labs, IT, Software Quality, LIMS/Empower 3 developers, and validation writer) for initial deployment to US and Switzerland Quality Lab Sites and support new product launch. Labware LIMS and Waters Empower 3 Admin.Collaborated with direct reports to develop annual goals, succession planning, and provided mid-year and year end performance reviews in Work DayManage Department Capital expense budget for all Quality Lab Capital projects.Manage Operational expense budget for Quality LabsNine years of Instrumentation: HPLC, GC, GC-HS, IC, AA, UV-Vis, FTIR, TOC experience in cGMP/cGLP laboratory.Nine years of laboratory wet chemistry and physical testing in FDA regulated environment. Eleven years compliance remediation to improve Quality Management System (QMS)Three (3) years of HPLC and GC method transfer from R&D to QC.Organized professional with strong oral and written communication skills, multi-tasking. Works well independently and as part of a team. Hazardous Materials Industry Technician # IT-R394552, California - Governor’s Office of Emergency Services
Experience
Business Solutions Manager
Jun 2023 — Present · Irvine, CA, US
Education
University of Sussex, United Kingdom
International Relations & Macroeconomics
2002 — 2002
UC Irvine
Bachlor of Science, Chemistry
Skills
- Sop
- Fda
- Hplc
- Uv/Vis Spectroscopy
- Chemistry
- Uv/Vis
- Lims
- Method Transfer
- Ir
- Gas Chromatography
- Laboratory
- Capa
- Ftir
- Wet Chemistry
- Usp
- Quality Control
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