Diane Reyes

About Diane Reyes

Experienced professional in the pharmaceutical, and medical devices environment, specialized in project documentation around testing/validation procedures, records management, technical writing, Quality Management Systems, and supply chain. Equipped for fast-paced work and changing daily needs- I am an analytical, detail-oriented, organize, highly flexible and adaptable, sensitive to timelines and deliverables, customer-focused, patient-oriented, dependable, decisive hard worker, Team player, self-started, problem-solving, a doer and achiever- Capable of coordinating several activities at once, quickly analyze, resolve specific problems, and cope with deadlines- Web portal skills at an advanced level- Experienced in computer platforms & applications: SAP, Mapics, CONDOR, D2ESOPS, Track Wise AQWA-A, CPSIA, Up4Growth, MS Teams, Outlook, Lotus Notes, Pilgrim, IsoTrain, Visio, Microsoft Office, EDM, Compliance Wire, WorkSense, Internet, and electronic mail- Knowledge of Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), GxP, Environmental Health & Safety program, practice oriented, company standards in compliance with FDA requirements, and local government requirements- Led Purchase Requisitions for MRO upon to completion (Purchase Order), for construction supplies, services and other resources- Management of Budget for Capital Projects- Coordination of services (handled, assisted, managed and completion)- Fully Bilingual,(English and Spanish) excellent oral, written, and verbal communication skills- Accomplished QSE Work Plan for FDA Consent Decree, and Audits.

Experience

1. Sr Tech Writer Consultant

   Black Diamond Networks

   Jul 2024 — Present · US

Education

• UPR RP

  Bachelor of Business Administration (BBA), Operations Management, Supply Chain, and Production / Manufacturing

  2007 — 2013

• University of Puerto Rico-Rio Piedras

  Bachelor of Business Administration (BBA), Operations & Supply Management (Production)

  2007 — 2013

Skills

• U.s. Food and Drug Administration (Fda)
• Design of Experiments
• Manufacturing
• Iso 13485
• Quality Assurance
• Analysis
• Software Documentation
• Root Cause Analysis
• Corrective and Preventive Action (Capa)
• Medical Devices
• Capa
• Technical Writing
• Quality System
• V&V
• Document Management
• Process Simulation
• Cross-Functional Team Leadership
• Quality Control
• Gmp
• Six Sigma
• Quality Auditing
• Engineering
• Standard Operating Procedure (Sop)
• Management
• Testing
• Sap
• Change Control
• Minitab
• Dmaic
• Validation
• Leadership
• Iso
• Pharmaceutical Industry
• Sop
• Fda