Analyst with a strong technical foundation and extensive experience in the pharmaceutical and medical device industry. Proven track record in production, quality assurance, and troubleshooting with a high level of organization, adaptability, and attention to detail. Proven ability to analyze complex systems and troubleshoot issues effectively. Skilled in MES, SAP, GMP, and GDP with additional expertise in root-cause analysis, electronic system management, and process improvement. A strong commitment to teamwork, reliability, and efficiency.
Technical Proficiencies: Microsoft Office Suite, SAP, MES, Factory Works, HMI, PLC, and Validation Processes (IQ, OP, PQ)
Process Improvement: Root-cause analysis, Failure Mode Effects Analysis (FMEA), and process documentation
Quality and Compliance: GMP, GDP, Auditing, Product Inspection, Batch Record Review, and SOP creation
Inventory & Logistics: Inventory management, Cycle Count Reports, Shipping Software (UPS, FedEx), CCSF, IATA, and DOT Certified
Team Collaboration & Leadership: Team-oriented with leadership qualities; Train the Trainer certified; excels in cross-functional collaboration Strong problem-solving and analytical skills