Led a QA floor support team, ensuring full compliance with Minaris policies and standards while supervising and coordinating daily QA staff activities to maintain efficient workflow and timely task completion. Facilitated training sessions on quality assurance requirements and processes and provided technical expertise in tech transfer activities. Managed the Batch Issuance and Batch Record Tracking System, reviewed and approved SOPs, Work Instructions, and Forms, and initiated and oversaw critical change control processes. Assisted in gathering information and supporting cGMP, client, and regulatory agency audits. Supported continuous improvement initiatives and coordinated job rotation and cross-training programs. Made informed decisions within established practices and policies, effectively handling non-routine issues, and conducted supervisory responsibilities, including hiring, training, and performance evaluations. Additionally, conducted raw material inspections, reviewed and disposed of batch records, ensured adherence to aseptic behavior standards in a clean room environment, and conducted internal audits to maintain compliance and quality standards.

- Lead and manage the Quality Assurance Shop Floor (QASF) operations in accordance with Bristol Myers Squibb's quality standards, regulatory requirements, and best practices.- Ensure compliance with study protocols, standard operating procedures (SOPs), and applicable regulations within the QASF.- Oversee data management, compilation, and calculation of test results, as well as statistical analyses.- Collaborate with cross-functional teams to write study summaries and comprehensive final reports for submission to sponsors.- Maintain research study files according to FDA and GCP regulations for IND studies.- Facilitate the submission of research protocols, safety information, and regulatory documents for IRB approval.- Interact with clients to maintain existing accounts and provide assistance as needed.

- Conduct specific departmental responsibilities as assigned by the Director of Photobiology.- Ensure accurate, consistent, and compliant review of Photobiology study data, documents, records, and folders.- Review and integrate standard operating procedures, protocols, and regulatory requirements into laboratory operations.- Manage data compilation, test result calculations, and statistical analyses.- Write study summaries and final reports submitted to sponsors.- Create and maintain research study files according to FDA and GCP regulations.- Facilitate the submission of research protocols and safety information for IRB approval.- Assist the Director in maintaining existing client accounts.

- Planned and oversaw daily activities of QA Department Auditors in alignment with operational priorities and the CPTC Quality Management System.- Ensured timely review of CPTC study data, documents, records, and reports for accuracy, completeness, and compliance with quality management system requirements, study protocols, and regulations.- Monitored and audited laboratory operations and procedures to maintain compliance with quality management system requirements and regulations.