Matthew Grella

About Matthew Grella

Senior level compliance professional with solid history of effectively creating, facilitating, implementing and maintaining Quality Management Systems for successful compliance. Broad knowledge and success in working with Regulatory Agencies, Boards of Health, cGMP, ISO, AABB, GxP, and other requiring bodies. Proficient in identifying and managing risk. Skilled trainer and leader; able to direct multiple tasks effectively and readily master innovative tools to get the job done. Collaborative communicator that excels at bringing teams together to resolve complex problems. Adding tremendous value to the organization by ensuring that all applicable regulations and agency guidelines are followed; continuously managing key compliance areas. Prepare process verification, stability protocols and reports. Provide documents and support Regulatory filings. Support R&D for method and product transfer to the CMO\'sQuality Compliance & Assurance / Risk Management / Deviation, Nonconformance, CAPAChange Management / Troubleshooting & Issue Resolution / Research & Implementation

Experience

1. Quality Assurance Specialist

   June Jacobs Labs, Llc

   Oct 2024 — Present · NJ, US

   Process ValidationFill / Pack ValidationAnnual Product ReviewNon Conformance and OOS Investigations

Education

• Empire State University

  Bachelor of Business Administration - BBA, Business Administration and Management, General

  2000 — 2006

• Empire State University

  Bachelor of Science, Business Administration and Management, General

Skills

• Cross-Functional Team Leadership
• Engineering Change Control
• Iso 9001
• Internal Audit
• Gmp
• Design Control
• Change Control
• Complaint Management
• Process Improvement
• Iso Management Representative
• Product Development
• Quality System
• Document Management
• Validation
• Iso 13485
• Quality Assurance
• Medical Devices
• Capa
• Fda
• Non-Conforming
• U.s. Food and Drug Administration (Fda)
• Manufacturing