Sean K. has a diverse work experience spanning over several companies and roles. Sean began their career as an Organics Extraction Chemist at Alpha Analytical in 2007. Sean then moved on to Genzyme, a sanofi company, where they held multiple roles, including QC Analyst I and II, and Quality Control Technical Services - Senior Analyst. At Genzyme, Sean was responsible for assay development and validation for lysosomal storage disorder therapy, as well as conducting various QC release assays.
In 2015, Sean joined SeraCare Life Sciences as a Senior Quality Technical Specialist. Their responsibilities included complaint handling, managing CAPAs and NCMRs, leading cross-functional teams in investigations, and driving procedural improvements in QC/QA.
Sean then joined GE-Healthcare in 2016 as a CAPA Leader in Quality Assurance. Their role involved leading CAPA activities, ensuring regulatory compliance, reviewing and approving qualification protocols/reports, and conducting mock audits to identify areas for improvement and increased compliance.
In 2018, Sean joined Emergent BioSolutions as a Specialist II in QA Compliance and Quality Systems. Sean later took on the role of QC Raw Materials Manager (Interim) in 2020-2021.
Currently, Sean is working at Neurotech Pharmaceuticals, Inc. as the Associate Director of Data Governance and Compliance, starting from May 2023.
Throughout their career, Sean has demonstrated a strong commitment to quality assurance, compliance, and improving processes within the organizations they have worked for.
Sean K. earned a Bachelor of Science (B.S.) degree in Environmental Biology from Plymouth State University, where they studied from 2002 to 2006. In addition to their degree, they have obtained certifications in CPR/AED/First Aid from the American Safety and Health Institute in March 2023, and in First Aid, CPR, AED from the National Safety Council in October 2016.
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