Lori Depetris

Experience

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  American Red Cross

  Feb 1998 - Dec 2016

  Quality Assurance Officer

  •Prepares, hosts and closes out internal and external inspections/audits and responds to audit observations.•Represents QA and/or leads projects, work groups or multi-functional process improvement, change control, consolidation and standardization teams.•Works collaboratively with Operations and Problem Management in problem solving activities or functions. Experience in root cause analysis and development of preventative and corrective action plans. •Evaluates operational processes and proposes quality improvements.•Stop the manufacture and /or distribution of biomedical products/services should it be determined that the safety, purity, quality and/or potency of the product or process has been compromised.•Responsible for problem solving, compilation of quality metrics and communication of compliance status to national management, staff, and external customers. •Ensures compliance with FDA regulations and Good Manufacturing Practices (GMP) •Participates on interview panels for Manufacturing Departments.•Responds to FDA observations and prepares and performs FDA reporting to Center for Biological Deviation Reports.•Responsible for writing and reviewing SOPs for Manufacturing Systems. Show less

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  Cook MyoSite

  Mar 2016 - Mar 2020

  Senior Quality Assurance Manager
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  OMNOVA Solutions

  Mar 2020 - Jan 2024

  Sr Quality Manager
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  Technimark LLC

  Jan 2024 - now

  Quality Manager