Sandip Mistry Email & Phone Number

• Results-driven QC Scientist with 8+ years of experience in the Biotech/Pharmaceutical industry, specializing in LIMS management, data analysis, and quality control operations.• Extensive knowledge of Lab Information Management Systems (LIMS), including GLIMS, Lab Vantage, MODA-FDC, MODA-EM, Track Wise, SAP, and Power BI. Proficient in data entry, system troubleshooting, and data integrity.• Expertise in microbiological testing, including bioburden, endotoxin testing (LAL), growth promotion, microbial limit testing, and environmental monitoring (EM).• Skilled in system configuration, database validation, report generation, and ensuring compliance with regulatory standards (cGMP, GLP, FDA, ISO 17025).• Experienced in programming languages Java, Python, JavaScript, Oracle Database, SQL Server, MQL, Informatica ETL, Unix Scripting, and Crystal Reports.• Proficient in SDLC and Agile model delivery & in ITIL and ITSM process integrations.• Utilizing GitHub and JIRA to regularly store, share and collaborate with the team on various tasks and ticketing.• Experienced in troubleshooting LIMS issues, software installation, and database management (SQL Server), ensuring system reliability and data accuracy.• Strong communicator with exceptional interpersonal skills and the ability to work cross-functionally to resolve issues and improve workflows.Technical Skills:• LIMS Systems: Lab Vantage LIMS, MODA-FDC, MODA-EM, Track Wise, SAP• Software & Data Management: Power BI, JDE Inventory, Microsoft Office Suite (Excel, Word, Outlook, Project), Adobe, Java, Python, JavaScript• Testing & Analysis: PCR, HPLC, Gel Electrophoresis, Gas Chromatography (GC), Endotoxin Testing (LAL), Microbial Testing, Bioburden, Growth Promotion• Compliance: cGMP, GLP, CFR, FDA Regulations, ISO 17025, SOP Development, CAPA• Technical Support: LIMS Configuration, SQL Database Management, Software Troubleshooting, Server Backup/Restore

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  University Of Maryland Baltimore County

  Bachelor'S Degree