Records Specialist Associate
Thousand Oaks
I worked as a Contingent Worker for Amgen. Specifically, I was in Records & Information Management, which included Document Management & Record Retention, and Inspection & Audit Readiness. My responsibilities in each include managing paper documents for studies that are considered ongoing as well as studies considered intermittent, and include any Preparation needed for the Management of Regulatory Inspections and Audits done internally or by the FDA. My job is to retrieve documents pertaining to a specific study, from which I secure, store (either on site or send off site), classify, identify and track, and preserve Paper TMF documents. My purpose is to ensure that the Paper TMF's maintain compliance through governance and risk management. I am familiar and work in Excel, Veeva, Epic, EDM Quality, TMF Classification, Document Quality Control, RIM, Product Compliance and SOP's including Global Code of Ethics for Clinical Trials, Global Research and Development Quality, Corporate Compliance Policies, Clinical and Nonclinical handling for PV Service Providers and Investigator Sites, and Research and Development Requirements.