Quality Assurance Manufacturing Engineer

Lucia L. Lagarejos

**** ********* *****, *********, ********** 94565

Cell: 925-***-**** ~ E-mail: ***********@*****.***

Objective

Highly motivated and detail-oriented professional seeking a position as a Quality Specialist.

Key Skills

Strong background in spreadsheet development and Validation.

Implementation of Process Improvement via Change Orders.

Excellent verbal and written communication skills.

Versatile ability to work well with others and/or independently.

Effective prioritization skills.

Professional Experience

Prime Analytical Laboratories, Concord, California 2023 – Present

Quality Assurance Officer

Reviewed and approved all documents, ensuring compliance with Regulatory bodies.

Regulated systems to maintain, monitor, and improve the Quality Management System.

Managed and coordinated all internal audit, customer and accreditation inspections.

Prepared and maintained trend reports for continuous process improvement consideration.

Generated Management and Quality System Review Reports.

Organized and archived all documentation.

Performed training on new or revised SOPs, and updated Employee Training matrices/records.

Alstom/Bombardier Transportation, Pittsburg, California 2019 – 2023

Supplier Quality Incoming Inspector

Created, monitored, and closed Non-Conformance Reports.

Performed Receiving inspections and released all incoming parts.

Investigated and reconciled inventory discrepancies.

Inspected car assemblies and resolved any observed issues with the Customer.

Provided continuous support for the Product Line Assembly.

Hitachi Rail, USA Inc., Pittsburg, California 2017 – 2019

Quality Control Inspector

Inspected and verified mechanical and electrical assemblies of bogies and train cars.

Reviewed and confirmed completion of production work instructions.

Collaborated with Production and Engineering to revise and improve Manufacturing Inspection Plans, associated drawings, and Bill of Materials.

Bio-rad laboratories, Benicia, California (Seattle Operations) 2006 – 2014

Manufacturing Engineer (ME)

Authored, modified, and implemented manufacturing procedures and validation protocols via Change Control Order process.

Interfaced with Project teams for new products and throughout the Product Life Cycle.

Participated in Root Cause Analysis and managed the FMEA Project files.

Trained Manufacturing departments during the transfer of new products.

Streamlined Excel spreadsheet validation requirements.

Dispositioned nonconforming materials and process deviations.

Purchased, validated and conducted training sessions on new laboratory equipment.

Bio-rad laboratories, Hercules, California 2001 – 2006

Manufacturing Engineer (ME)/Project Manager (PM)

Developed and revised procedures for Process Improvement and conducted associated training sessions.

Authored and executed equipment Validation Protocols (IQ, OQ, PQ).

Initiated, investigated, and implemented corrective actions on Non-Conformance Reports.

Monitored and ensured all involved project tasks are fulfilled on a timely manner.

Managed, scheduled, chaired project team meetings, produced Meeting Minutes and carried out assigned action items.

Served as the liaison for communication within numerous company Divisions.

Generated multiple Design Control documents, compiled, indexed and submitted the comprehensive Project Files.

Microgenics, Freemont, California 1999 - 2001

QA/QC Chemist

Conducted routine analysis of finished products using automatic analyzer to support the Product Surveillance program.

Scheduled and trained new team members.

Analyzed, summarized stability data for newly developed assays, and issued expiration dating of products.

Roche/Boehringer-Mannheim, Pleasanton, California 1995 - 1998

Research and Development Chemist

Formulated bulk buffers and reagents per manufacturing procedures.

Executed experiments on automated analyzers in the characterization, optimization and validation of reagents.

Compiled, analyzed and presented collected data.

Education & Other Courses

B. S. in Biological Science, University of California, Davis, California, 1988

Microsoft Products: Excel, Word, Power Point, Outlook. Project (Management) and FMEA tools

Enterprise Resource Planning: SAP, JIRA, ASK (ManMan), JDEdwards and Solochain/AVM databases

Courses and Training: Project Management Principles, Excel Spreadsheet Validation, Lean Six Sigma, 8D, QRQC, OSHA, Crane and Forklift Operation Training, First Aid/CPR/AED

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