• and ensuring full compliance with GMP and regulatory standards.• Led batch disposition activities, ensuring all products met quality standards and regulatory compliance.• Developed internal controls and corrective actions to mitigate compliance risks, ensuring strict adherence to quality management systems.• Partnered with internal teams to streamline processes, conducted mock audits, and introduced process improvements, reducing error rates by 15%.• Provided on-the-floor coaching and troubleshooting to resolve deviations and prevent potential issues in real-time.• Contributed to mock regulatory audits, ensuring ongoing inspection readiness and compliance.• Spearheaded root cause analysis for process deviations, leading to improved operational efficiency and 20% reduction in compliance-related issues.• Maintained proficiency in Veeva Vault, SAP, Oracle, and LIMS, in supporting batch release and compliance workflows

• • Established and led a 2nd shift team overseeing the entire lifecycle of cryogenic and temperature-sensitive samples.• Designed optimized workflows for sample tracking and storage, improving efficiency by 25% and reducing errors in sample handling.• Implemented automated solutions to streamline inventory management and minimize manual tracking errors.• Collaborated with cross-functional teams to ensure streamlined operations and timely communication of quality events

• • Coordinated receipt, storage, and management of GMP-compliant samples, utilizing LIMS for accurate inventory tracking.• Ensured timely documentation and traceability of all sample management activities, achieving 100% audit readiness.• Collaborated with cross-functional teams to enhance sample management protocols, reducing processing time by 10%.

• • Supervised a team of five in the production of human skin preparation for cancer treatment, ensuring compliance with safety and quality standards.• Led continuous process improvement initiatives, reducing downtime by 12% and improving overall production efficiency.• Collaborated with cross-functional teams to enhance manufacturing workflows, reducing errors and improving adherence to production schedules.• Aseptic Processing and Sanitization in Biosafety Cabinets

• Used an aseptic technique to work in the clean room.• Part of the Splitter Team that works with human skin and prepares it for packaging.• Performed tasks of preparing solutions to soak the skin in. Managed production support and biohazard waste removal. Followed SOPs, GMPs, GDPs