Michelle Fiordalisi
Qc Manager (Interim) and Tech Writer @Amris
Signup · Get unlimited contacts
WORK HISTORY
Qc Manager (Interim) and Tech Writer @Amris
Durham, NC, US
Promoted from Technical Writer to QC Manager (Interim) within 4 months of hire and assumed additional responsibilities during the absence of Quality Manager.• Repeatedly took the initiative to identify process gaps and devise solutions. Identified and drove projects to improve user knowledge and experience with ERP systems and formulated User Management strategy for analytical instruments.• Was instrumental in investigating and resolving LIRs, deviations, and CAPAs
EDUCATION
Washington University in St. Louis
Doctor of Philosophy (Ph.D.), Molecular Immunology and Biochemistry
Wake Technical Community College
Continuing Eduction certification, cGMP Biomanufacturing
Lawrence University
BA, Biology
SKILLS
ABOUT MICHELLE FIORDALISI
Stepping into the role of QC Manager (Interim) at AMRIS Consulting, my expertise in Quality Investigations has been pivotal in enhancing the Quality Management System (QMS). At the heart of my approach lies a commitment to safeguarding compliance and streamlining processes, which I have honed through hands-on leadership in Quality Assurance and Quality Control. My recent endeavors include spearheading projects that significantly improved ERP systems and user management strategies for analytical instruments.Prior to my current role, my tenure as Associate Director at Precision BioSciences, Inc. was marked by successful collaborations across Analytical Development, CMC, Manufacturing, and QA to ensure QC operations were robust and business-aligned. My focus was on developing and maintaining phase-appropriate QMS and driving the technical transfer of new methodologies, which was integral to the growth trajectory of our company. This experience solidified my proficiency in FDA and GMP compliance and underscored my dedication to advancing cell and gene therapy manufacturing with precision and passion.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.