MD

Michael Danksewicz

Quality Assurance Operations Lead at EyePoint Pharmaceuticals

Michael Danksewicz has worked in various roles related to quality assurance in different organizations.

From 2023 to present, they have been working as a Quality Assurance Operations Lead at EyePoint Pharmaceuticals. In this role, they are responsible for reviewing internal and external site documentation for cGMP quality compliance, performing line clearances and material releases, and leading the execution and closure of change controls, CAPAs, deviations, and risk assessments.

Prior to this, from 2021 to 2023, they served as a Quality Assurance Specialist I at Curia (formerly AMRI). Here, their responsibilities included reviewing site documentation for quality compliance and GDPs, assisting cross-functional teams with change controls, CAPAs, deviations, and risk assessments, and performing AQL testing on manufactured products for regulatory compliance.

From 2018 to 2021, they worked at Dunkin' Brands in two different roles. As a Quality Assurance Food Technologist for Bakery, Savory, and Packaging from 2019 to 2021, they maintained the Dunkin QA helpline, assisted key development projects, and evaluated products for QA compliance and approval. As a Quality Assurance Specialist from 2018 to 2019, they assisted the regulatory team with the transition of nutrition fact panels, facilitated the transfer of ingredient specifications to a database, and maintained recipe builds, ingredient statements, and fact panels.

Prior to their roles in the pharmaceutical and food industries, Michael Danksewicz worked as a Food Service Intern at Norwood Public Schools for a brief period in 2016.

Michael Danksewicz obtained a Bachelor's degree in Food Nutrition and Wellness from Framingham State University from 2011 to 2016.

Links

Previous companies

Curia Global logo

Timeline

  • Quality Assurance Operations Lead

    January, 2023 - present