Sally Varese

• Partner with cross-functional stakeholders to deliver accurate technical reports and standardized documentation supporting quality, compliance, and customer satisfaction.
• Develop and standardize SOPs, templates, and reporting processes to improve operational efficiency and reduce process variability.
• Review testing requests and results to ensure alignment with customer requirements, specifications, and quality expectations.
• Used technical drawings to evaluate engineering stack-up tests for tooling validation and component assembly

• Led supplier and contract manufacturer investigations, CAPA implementation, and performance monitoring across regulated manufacturing environments.
• Conducted vendor qualification and supplier evaluations, assessing quality, compliance, reliability, and operational performance.
• Developed KPI reports and statistical analyses to monitor consumer complaints, supplier performance trends, and quality risks.
• Partnered with internal manufacturing teams and external suppliers to drive corrective actions, continuous improvement, and supply continuity initiatives.
• Supported risk mitigation strategies through data analysis, CAPA management, and cross-functional collaboration.

• Managed vendor relationships supporting tooling design, equipment procurement, and manufacturing implementation projects.
• Developed procedures for manufacturing scale down and ran process validations.
• Led process optimization and cost reduction initiatives to improve manufacturing efficiency and reduce cycle times.
• Executed equipment qualification activities (IQ/OQ/PQ) and supported risk mitigation through structured root-cause analysis and CAPA.
• Collaborated with Operations, QA, QC, and external suppliers on product launches, scale-up activities, and process improvements.
• Developed and maintained SOPs, specifications, change controls, and validation documentation supporting regulated manufacturing operations.

• Prepared packaging safety assessments and material equivalency reports, supporting packaging qualification and regulatory compliance.
• Managed change controls and technology transfer processes while ensuring timely implementation and stakeholder alignment.
• Analyzed manufacturing and laboratory data to identify recurring issues, mitigate risks, and drive corrective actions.
• Supported packaging-related compliance initiatives under FDA and USP requirements in regulated manufacturing environments.

March 2017 – February 2019

• Analyzed and investigated catalyst active sites and development methods for root cause analysis of catalytic deactivation using methods of analytical chemistry and statistics.

• Modeled and automatized the process of sample preparation and measurements ensuring high accuracy, efficiency and fast results.

• Optimized experimental parameters using Minitab, that involved product performance evaluation.

• Worked independently and as a team member evaluating product performance both, in Pilot Plant and lab.