Brian Murray

About Brian Murray

For the past 7 years, I\'ve had the pleasure of working at Regeneron in Rensselaer, NY. I started out as a Batch Record Reviewer for Clinical Manufacturing, but quickly transitioned onto the QA MES team, where I\'ve collaborated on the MES side by side protocol, reviewing and approving Design Specifications and Master Batch Record Designs to ensure equivalency with our paper batch records.I\'m currently looking for a QA MES Engineer position. Please do not inquire about Validation opportunities as I am not interested at this time.Previously I worked at Wyeth/Pfizer in Pearl River, NY site for 11 years. Here are some highlights:Senior Technical Services Validation Specialist: Authored protocols and reports for Cleaning Validation and Verification, Process Validation, Media Simulations, Filter Validation, Buffer Hold Time and Development studies. I authored or provided support to Operations, for investigations of any observed deviations found during execution, as well as providing change control input, as required.Senior Technical Services Compliance Specialist: Site Validation Master Plan Mgmt, authoring investigations and performing root cause analysis/CAPA, Annual Product Quality Review coordination, conducting internal audits, participating in housekeeping audits, developing and reporting metrics to senior management, purchasing, leading and participating in many continuous improvement activities, and the managing/tracking of commitments, change controls, training, periodic reviews, investigations and projects for the department, in addition to my previous equipment calibration coordination responsibilities. Equipment Specialist: Developed and implemented the restructuring of the validation equipment department, consisting of over 400 saved through continuous improvement projects. Authored investigations, budgets, purchased new validation equipment, logbook/document records mgmt. and achieved 100% on-time accuracy for the delivery and completion of over equipment calibrations.

Experience

1. Senior Quality Assurance Specialist

   Regeneron

   Jan 2024 — Present · Rensselaer County, NY, US

Skills

• Biotechnology
• Process Engineering
• Technical Writing
• Microsoft Word
• Software Documentation
• Good Laboratory Practice (Glp)
• Capa/Root Cause/Investigations
• Pharmaceutical Industry
• Sop
• Standard Operating Procedure (Sop)
• Manage Inventory
• Quality System
• Microsoft Office
• Process Simulation
• Continuous Improvement
• Cgmp Practices
• Calibration
• U.s. Food and Drug Administration (Fda)
• Manuf
• Documentation Practices
• Trackwise
• Validation Master Plans
• Microsoft Outlook
• Operational Excellence
• Cleaning Validation
• 21 Cfr Part 11
• Copy Editing
• Computer System Validation
• U.s. Title 21 Cfr Part 11 Regulation
• Risk Management
• Lims
• Corrective and Preventive Action (Capa)
• Microsoft Access
• Internal Audit
• Biopharmaceuticals
• Gmp
• Verification and Validation (V&V)
• Laboratory Information Management System (Lims)
• Change Control
• Manufacturing