Aarti Yadav

Detail-oriented Biotechnology professional with 3+ years of experience as a Quality Control Analyst at the National Institute of Biologicals (NIB), with experience in biological sample logging, analytical data review, data entry, data integrity checks, report generation, SOP execution, regulatory compliance, and audit readiness. Experienced in ALCOA+ data integrity principles, NABL ISO/IEC 17025:2017 requirements, Corrective Action (CA) workflows, and IQ/OQ/PQ activities. Currently enrolled in an Advanced Course in Clinical Research and developing theoretical knowledge of clinical data management concepts including CRF/eCRF, data entry, validation, discrepancy/query management, data reconciliation, EDC workflows, ICH-GCP, CDSCO, FDA/EMA concepts, and 21 CFR Part 11.

Seeking to transition into a Clinical Data Coordinator role while building on a strong foundation in quality, documentation, data integrity, and compliance.

Quality Control Analyst / Bench Biologist at National Institute of Biologicals (NIB), Ministry of Health & Family Welfare, Govt. of India (2022-10 – Present)

• Manage initial intake of biological samples, systematic batch logging, and end-to-end traceability across database portals and physical records.
• Review analytical testing raw data and verify testing outputs against defined regulatory acceptance criteria before final report generation.
• Capture analytical results, process testing data, and generate official Certificates of Analysis (CoA) through a centralized web portal.
• Perform data integrity checks and maintain accurate, complete, and traceable records in accordance with applicable quality requirements.
• Author, maintain, and execute Standard Operating Procedures (SOPs) based on Indian Pharmacopoeia (IP) requirements.
• Assist with root-cause analysis and Corrective Action (CA) workflows and participate in equipment qualification activities (IQ/OQ/PQ).
• Maintain audit readiness and support compliance with NABL ISO/IEC 17025:2017 requirements and ALCOA+ data integrity principles.
• Perform calibration and routine quality checks of micropipettes and precision laboratory instruments to maintain measurement accuracy.
• Provide onboarding and practical training to interns and scholars on documentation, laboratory safety, and regulatory compliance.

Master of Science (M.Sc.) in Biotechnology – Jai Narain Vyas University, Jodhpur (2019 – 2021)