• Develop and implement continuous improvement strategies, initiatives, and training materials.• Lead cross-functional teams to identify areas for improvement and develop action plans.• Facilitate Weekly/Monthly Leadership Meeting, Lean Steering Committee Meeting, Cost Savings Meeting, and Policy Deployment Meeting.• Facilitated a project for a Direct-to-Consumer process that improved throughput by 100% in 2021 and received Spotlight on Excellence Award.

• Facilitated focus improvement kaizens to identify barriers to flow and brainstorm solutions to improve the workflow for the Batch Record Review, OOS, and NCR processes. • Led a cross-functional team to map and streamline the batch record review process in Softgel manufacturing that reduced the review time by 56% and improve on-time by 30%.• Led a cross-functional team to map and streamline the batch record review process in Tableting manufacturing that reduced the review time by 65% and improve on-time by 159%.

• Participated in the planning and design of the new Laboratory Information Management System (LIMS).• Developed actionable risk mitigation strategies and monitoring metrics for various projects, that allowed for a smooth transition of daily laboratory duties from QA inspectors to QC chemists.• Participated in the planning and design of the QC and Micro laboratory renovation plan. • Partnered with third party laboratory to do testing for QC lab during renovation.• Developed training matrix for the QC chemists due to new responsibilities and an added shift. • Updated OOS investigation process, and developed metrics to monitor OOS closure time. Ensured teams responded appropriately to OOS and NCR; closure time improved by more than 50% by year end.

• Led a team of 20 in Tableting manufacturing for the first 2 years, 10 of which were direct reports.• Led a team of 20 in Softgel manufacturing for the second 2 years, 10 of which were direct reports.• Experience in granulation, blending, compressing, coating, and inspection in the Tableting.• Experience in gel making, compounding, encapsulation, inspection, and enteric coating in the Softgel.• Supervised daily activities to ensure that productivity and quality objectives are met or exceeded. • Routinely communicated with employees on safety and health rules to ensure safe practices are being performed. • Participated in a Softgel inspection kaizen that achieved a savings of about $117,000 annually by eliminating DPR sampling, and revising AQL sampling and piece weight determination procedures. • Participated in a Softgel inspection kaizen that reduced the number of SOPs by 82%.

• Developed and implemented SOPs, test methods, and other documents required for all aspects of production.• Oversee Quality Assurance function and ensure consistent and accurate quality for all materials related to product line in a cGMP environment, adhering to FDA regulations.• Performed internal audits and quality systems of vendors to ensure compliance with regulatory policies and procedures.• Investigated and established stability and quality of existing products, and worked with the team and vendors to resolve on-going issues.• Tracked lab test failures, conducted root cause analysis and took corrective action, advised management team on trends and critical issues.

• Led a team of 2 technicians.• Participated in weekly activities with various departments to track and report, prevent, and reduce MRB (Material Review Board) rejects. • Upgraded and monitored, and fixed existing processes. • Supported the conversion of small-scale processes into commercially viable large-scale operations.

• Performed physical and chemical testings on raw materials, in-process samples, stability samples, and finished products for vitamins, minerals, and other supplements.

• Developed and validated robust analytical methods for in-process testing, cleaning samples testing, and final product release as well as oversaw raw material testing. • Performed method transfer validation on formulations provided by contract manufacturers. • Formulated drug products in small batches for studies. • Scheduled preventative maintenance and calibration of equipments. • Maintained lab notebooks, log books, and material inventory. • Wrote and reviewed Testing Method Validation Protocols, Cleaning Method Validation Protocols, Laboratory Testing Procedures (LTMs), Standard Operating Procedures (SOPs), and Out of Specification (OOS) reports.