serina ortiz

* Created Technical Operation Procedures. * Prepared Annual Reports to be reviewed by regulatory personal and Food and Drug Administration (FDA). (250 Annual Reports annual) * Maintained an Access database of all product change control documents for multiple sites (Monthly Reports, Test Methods, Process Validation Reports, Batch Manufacturing Records, Labeling, Stability and Annual Review Reports.) * Coordinated with Regulatory Compliance to guarantee all current documentation is in compliance with FDA Regulations as well as company policies, including Standard Operation Procedures and Current Good Manufacturing Practices. * Maintained a precise off site storage database file.

* Company Documentation Transfers – Tracked all documents and maintained a high level of accuracy during transfers. Handled all contacts and inventory maintenance. * Worked with Managers and Supervisors in preparation reports, investigations and FDA audits. * Assisted in releasing finish products and raw materials. (Audit review checks, Generating Batch Manufacturing Records) * Created Technical Operation Procedures for the department and designed/created internal documents. * Supervised volunteers and interns. * Continued performing all duties as a Documentation Coordinator I.