Manujendra Saha
Quality Assurance Tester @IKO North America
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WORK HISTORY
Quality Assurance Tester @IKO North America
Conduct testing on key parameters associated with Quality Assurance of the raw materials and finished products to ensure that products comply with company, industry, and regulatory standards. •Identify quality issues in real time on the production floor and help production team troubleshoot and drives resolution of production quality deficiencies and problems. •Monitor quality impact of new products, processes, methods, or equipment. •Works with shipping and production team to ensure nonconformance products are sorted, segregated, and downgraded as per disposition procedures.
EDUCATION
Gunma University Graduate School of Medicine,
Doctor of Philosophy (PhD)
Western University
Translational Transplantation
University of Toronto
Laboratory Medicine and Pathobiology
SKILLS
ABOUT MANUJENDRA SAHA
I bring a unique combination of R&D and quality control experience. My commitment to quality allowed me to tackle complex challenges and transform cutting-edge discoveries into practical solutions. I thrive in fast-paced environments and have a proven track record of delivering 15+ projects and milestones within timelines. Education & Experience: PhD in Molecular Biology background with 8+ years of hands-on experience in cGMP-controlled manufacturing environment within pharmaceutical and biotechnology industries. QUALIFICATION SUMMARY Method Development and Validation: 7+ years experience in quality control and analytical method development and validation. Achieved 10% annual savings in testing costs. QC Release and Stability Testing Reduced test completion and product release time by 15%. Trained team in GMP-compliant QC testing and environmental monitoring. Leadership 8+ years of management experience as a laboratory manager and QC lead. Project Management Successfully delivered 15+ projects on time and within budget. Material Management Developed and implemented an efficient material management system. Investigation, quality audit, and Continuous Improvement Performed root cause analysis, Initiated corrective action plans for nonconformance, enhancing quality management. Relationship Building and Communication Fostered collaboration 🤝 with stakeholders to enhance team efficiency. Core Skills: LIMS | Empower | Chromeleon | U(HPLC)| LC-MS | GC | Capillary Gel Electrophoresis | ELISA | qPCR | Western Blot | Flow cytometry | Sequencing | Bioburden | Endodtoxin | Sterility | Cell culture | Cell Bank | cell viability assay | cytotoxicity | apoptosis assay | With a growth mindset, I continually seek opportunities to learn new technologies. My goal is positively impact people\'s lives by addressing complex challenges through my expertise in quality control functions and analytical development.
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