Providing tactile and sign language interpreting services

Process controlled documents: Master Batch Records, Validations, Specifications, Methods, Standard Operating Procedures (SOPs), and Forms; proofread documents for punctuation, spelling, formatting and accuracy; issued lab worksheets and notebooks; scanned; filed; audited master document binders; assigned document numbers and changed control numbers; distributed approved documents; and made photocopies

Generated and submitted over 150 pre- and post-approval submissions (both Investigational New Drug (IND) and Biologic License Application (BLA)) to the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER), divisions of the Food and Drug Administration (FDA). Responsibilities include scanning graphics and publications; assembling and formatting documents; creating cross references, bookmarks, hyperlinks, pagination and indexes; burning cds; maintaining electronic storage of documents on servers; developing department procedures; and troubleshooting computer applications