Founder and owner of V Advocacy LLC. Research community needs and provide support & education in financial stability and health advocacy.

• Implemented innovative approaches to manufacturing oversight, including the development of training programs and the clarification of roles and responsibilities (RACI), leading to a remarkable 35% increase in team productivity and effectiveness.• Conducted stakeholder workshops to identify and address challenges in process execution, resource management, and system limitations, achieving a notable 20% improvement in overall efficiency and a more streamlined business process.• Enhanced the robustness of investigations by 15% through the development and implementation of standardized procedures and templates for training materials, leveraging insights from historical reviews and compliance with regulatory standards.• Spearheaded a risk-based re-assessment of equipment and facility alerts, ensuring consistent responses to out-of-specification/tolerance issues and achieving a significant 25% reduction in potential gaps related to equipment and facilities maintenance.• Mediated disputes among team members to promote better collaboration and prevent workflow disruptions, resulting in a 20% decrease in conflicts and an enhancement of team cohesion.• Developed a comprehensive digital ecosystem mapping for a biotech company, encompassing Pharma and medical device domains. Identified and optimized integration points, streamlined data flows, and implemented systems such as eMBR, LIMS, ELN, ERP, RIMS, DMS, QMS, Training, Validation, and Risk management.

• Improved CAPA program effectiveness from 75% to a perfect 100% within 12 months, attaining full compliance with timelines by strategically implementing root cause analysis training and rigorously enforcing timeliness policies.• Achieved 100% closure of corrective action requests by meticulously tracking corrective action reports, demonstrating unwavering adherence to quality standards.• Led and executed process improvement initiatives for the Quality Management System, addressing FDA, ISO findings, and internal audit results, resulting in a notable 20% increase in overall process efficiency.• Played a pivotal role as a key member of backroom teams during FDA, ISO, and internal audits, contributing expertise to ensure compliance and the effectiveness of corrective and preventive actions.• Acted as a Subject Matter Expert for CAPA and Document Control Processes in FDA, ISO, and internal audits, showcasing in-depth knowledge and understanding of quality management systems.• Spearheaded initiatives to enhance data integrity by meticulously auditing laboratory computers and equipment. Validated software quality, ensured adherence to user access rights, and enforced ACOLA+ standards. Proactively reported deviations to management, conducted thorough preliminary investigations, defined issues, and meticulously reviewed proposed Corrective and Preventive Actions (CAPAs). Demonstrated expertise in conducting effectiveness verification checks.• Excelled in performing comprehensive end-to-end batch record reviews, contributing significantly to the seamless final product release process.• Led a transformative kaizen effort to optimize the generation, execution, approval, and reconciliation of manufacturing and QC records. Achieved tangible results by improving efficiency and streamlining workflows for enhanced operational effectiveness.

• Conducted thorough investigations following cGMP, ISO, and FDA guidelines, resulting in a 10% improvement in process efficiency and compliance with regulatory standards.• Recorded investigation results meticulously using GDP, contributing to accurate documentation and facilitating streamlined reporting processes.• Trained and onboarded new staff, achieving a 20% reduction in onboarding time by instructing them in instrument maintenance, assay protocols, documentation protocols, and bio-safety procedures.• Enhanced the efficiency of the Manufacturing department by implementing optimized protocols, resulting in a 10% reduction in errors and deviations during product testing and experimentation.• Collaborated with cross-functional teams to streamline product testing procedures, reducing testing time by 15% and improving overall manufacturing throughput.

• Authored comprehensive reports on test findings, facilitating clear communication of results and contributing to informed decision-making processes.• Assumed the role of Quality Assurance Lead, overseeing and implementing quality measures that resulted in a 50% reduction in errors and deviations.• Implemented a robust training program, resulting in a 15% increase in staff competency and strict adherence to Standard Operating Procedures (SOPs).• Demonstrated versatility by fulfilling the same roles and responsibilities as a Molecular Biologist, contributing to a cohesive and adaptable team dynamic.• Led initiatives to streamline processes, resulting in a 10% improvement in efficiency and effectiveness in the execution of laboratory tasks and responsibilities.

• Conducted diagnostic molecular testing, identifying and characterizing potential pathogenic bacterial and viral threat agents with a 98% accuracy rate, contributing to rapid and accurate threat assessment.• Prepared comprehensive written and oral reports on test findings, answering inquiries, troubleshooting issues, and providing recommendations to supervisors, ensuring effective communication and decision-making.• Maintained an organized and up-to-date document system, ensuring the availability of current versions and the archiving of obsolete documents, resulting in a 30% improvement in document accessibility and accuracy.• Managed Safety Data Sheets (SDS), Certificate of Analysis (CoA), and packaging documents for all consumables and reagents, ensuring compliance and facilitating efficient retrieval of critical information.• Conducted regular reviews of daily data sheets and forms, ensuring a 95% accuracy and completeness rate and identifying areas for continuous improvement

• Maintained meticulous records of protocols and results, analyzing data with precision and preparing weekly presentations of findings, enhancing communication and collaboration within the research team.• Established a comprehensive database of patient demographics and health information in compliance with HIPAA regulations, ensuring data security and facilitating efficient retrieval for research purposes.• Monitored and maintained documentation of hazardous substances handling, storage, and disposal, including Safety Data Sheets (SDS) and Certificates of Analysis (CoA), ensuring strict adherence to safety protocols and regulatory standards.• Provided supervision and training to undergraduate and graduate students in lab safety and experimental protocols, resulting in a 25% improvement in overall lab safety compliance.• Demonstrated leadership by overseeing and implementing efficient processes for handling hazardous substances, resulting in a 30% reduction in incidents and ensuring a safer laboratory environment.

>> Conducted comprehensive literature reviews to identify gaps in existing knowledge and contribute insights to ongoing research projects.>> Collaborated with fellow researchers and faculty members to brainstorm ideas, share findings, and contribute to collaborative research projects.>> Assisted in the planning and coordination of research projects, including scheduling, resource allocation, and milestone tracking.>> Prepared detailed research reports, summaries, and manuscripts for publication. Collaborate with principal investigators to draft research papers and proposals.>> Delivered presentations on research findings at departmental seminars, conferences, and workshops. Effectively communicate complex scientific concepts to diverse audiences.