Joan Kisembo
Quality Assurance Specialist at Moderna
- Role
- Quality Assurance Specialist at Moderna
- Location
- Attleboro, MA, US
- LinkedIn followers
- 500 followers
About Joan Kisembo
Seeking opportunities in Drug safety, Post Market surveillance, Pharmacovigilance regulatory affairs and quality assurance
Experience
Quality Assurance Specialist
Aug 2020 — Present · Norwood, MA, US
Support quality agreement execution including coordination of negotiations with suppliers, customers and or partners, documentation of those quality agreements, and tracking adherence to quality agreement requirements. · Support risk management activities including planning, design & risk assessment. · Applies statistical methods and design/process excellence tools to support global GxP compliance requirements. · Provide guidance in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions. · Provide guidance in the understanding of regulatory reporting (BPDR, EU Defect) to other disciplines. · Tracking metrics & initiate quality improvement plans to address problem areas. · Reviewing and approve quality plans, support investigations to provide root cause analysis and ensure effective corrective actions are taken. · Track, manage and execute market actions and or product recalls. · Support and manage global escalations / notifications. · Ensuring compliance, and drive improvement plans where needed. · Host status update meetings, create/review status reports for key projects.
Education
Regis College
Master's degree, Regulatory & Clinical Research Management
2015 — 2017
Regis College
Associate's degree, Registered Nursing/Registered Nurse
2019 — 2021
Regis College
Bachelor of Science - BS, Nursing
2021 — 2024
St.Joseph’s Naggalama
High School Diploma
2003 — 2007
Everett High School
High School Diploma
2008 — 2009
University of Massachusetts Amherst
Bachelor of Science - BS, Biochemistry and Molecular Biology
2010 — 2013
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