• Provide support on Corrective Action by providing metrics/analysis and reporting of improvements. • Generate and publish system quality compliance data related to NCs/CAPAs and guide the Investigation Owner in the application of structured problem-solving methodologies in Root Cause Analysis (RCA), investigations (Fishbone, 5 Whys, etc.), QMS Activities in Internal Audit governance and Supplier Quality.• Identify nonconformance and CAPA deliverables/timelines by running reports, communicating upcoming deadlines, and conducting NC/CAPA data trend analysis within TrackWise ETS QEM system.• Assist with Project Management initiatives across the Internal Audit program.• Develop training content and ensure training content is continuously updated with process improvements, accuracy, and completeness of pertinent record and documentation, including audit requests.

* Supported Corrective & Preventative Actions Process (CAPA). Incidents, issues, and risks are identified, and processed. Created and defined Action Plans. The action items are then verified and validated in timely manner. * Used Quality Management Methodology and Tools to facilitate fact-based decision making allowing ETS to reduce defects and continually improve processes. * Participated and performed Internal Quality System Audits. * Participated and performed Supplier Audits.

* Supported Corrective & Preventative Actions Process (CAPA). Incidents, issues, and risks are identified, and processed. Created and defined Action Plans. The action items are then verified and validated in timely manner. * Used Quality Management Methodology and Tools to facilitate fact-based decision making allowing ETS to reduce defects and continually improve processes. * Participated and performed Internal Quality System Audits. * Participated and performed Supplier Audits.

* Facilitated Risk Assessments related to the Biotechnology filling process. * Developed Risk Assessment Reports. * Ensured that all reports comply with policies and regulatory agencies.

* Evaluated sampling and inspection strategies related to the manufacturing of solid dosage OTC products. * Assured sampling and inspection strategies are aligned with product Quality Attributes and are developed using a risk-based approach. * Reviewed and revised operational procedures and protocols related to sampling and inspection activities. * Ensured that all documents comply with policies and regulatory agencies.

* Reviewed and approved the closure and risk assessment of NCEPs. * Provided support on NCEP’s investigations by providing data analysis tools and assistance. * Reviewed and provided feedback to NCEPs Investigations. * Supported CAPA activities and coordinated CAPA board review meetings. * Participated and performed Internal Quality System Audits.

* Served as a consultant in the Supplier Program and Incoming Activities. Responsible to review and align supplier specifications and procedures. * Resolved material quality issues, specifications, and inspection procedures questions at the incoming inspection area. * Evaluated suppliers’ internal functions to assess their overall performance and provided feedback in assessment of their operation. * Reviewed potential or material quality issues to coordinate corrective/preventive actions with suppliers. Applied problem-solving skills to the corrective action process and eliminated problem root cause through long-term preventive action.

* Responsible to provide coaching for the implementation of Standard Operating Procedures (SOP) Project. * Facilitated Kaizen Events using Lean and Six Sigma Methodology. * Responsible to support Transformation Leaders to drive Continuous Improvement, Culture Change and Standard Ways of working. * Responsible to provide technical and process expertise about SOP System and Structure. * Responsible to fill specific technical gaps in the team.

• Responsible for the alignment of specifications to four major suppliers: inspection procedures, manufacturing procedures and components specifications.• Responsible to review and align supplier specifications and procedures.

• Evaluated and assessed process situations along with the manufacturing area and provided technical input and performed troubleshooting of the process events.• Activated the Special Response Team (SRT) and acted as team leader to resolve events in the manufacturing process that could have an impact in the product.• Documented process events (no product impact) or escalated to Non Conformances (possible product impact) as determined by the Special Response Team (SRT).• Evaluated unusual trends related to the manufacturing process and established adequate corrective actions.• Accountable for the completion of the events and non-conformances of his/her area, as well as CAPA’s related to documentation or processes.• Evaluated the effectiveness of the corrective actions of his/her area.• Performed and reported metrics related to events and no-conformances of his/her area, and developed One Pager for trend reports.

• Accountable for the overall Supplier Quality Assurance System (program maintenance and development), including Quality System indicators integration, analyses, and provided feedback to the plant CAPA System.• Developed Quality Specifications and Process Control Techniques.• Responsible for the Quality Review of designated process validations.• Designed sampling plans and applied statistical techniques to improve process quality performance.• Identified, recommended and implemented initiatives for continuous process improvements.• Investigated, recommended and implemented corrective and preventive actions.• Developed Processes and Supplier Control Plans / Developed and reviewed FMEA’s.• Worked in the resolution of quality issues with suppliers and process owners.• Investigated customer complaints related to product, process and raw materials.• Established and maintained supplier product process quality metrics.• Led and supported the closure and analysis of product, process and supplier related NC and CAPA’s.

• Led the development and implementation of Quality Systems to assure process robustness and regulatory compliance.• Facilitated Incoming Inspections, Calibration Program, Process Auditing and Product Release.• Served as a consultant in the quality related operations and quality system applicable to the plant products and process.• Provided guidance and recommendations as needed.• Ensured all direct personnel were properly trained to perform their adding function in accordance with applicable GOP’s and WI’s.