Document Control Coordinator:Working with various Pharmaceutical companies, including extension long-term travel to Lincoln, NE, Fargo, ND, Irvine, CA and Bangalore, India. Working with experienced and seasoned X-FDAer's responsible included creating, collection, maintenance and distribution of FDA-Compliance IP controlled documents for pharmaceutical and medical device clients located both domestically and abroad. Responsible for set-up of documentation systems, examination of documents for verification and accuracy to assist in resolving discrepancies. • Tracked and maintained Quality Systems and remediation documents• Gathered, organized and assisted in the review of clinical and training documents for accuracy and completeness• Assisted in developing and maintaining databases containing master records, protocols, deviations, change controls and customer complaints in addition to Quality Assurance records, SOP's, compliance and regulatory documents• Performed preliminary reviews of document certification and examined documentation to verify completeness and accuracy and assisted in discrepancies on the controlled documentsInformation Research Analyst:Collaborated and conducted detailed searches upon consultants’ requests of FDA regulations, cGMPs, GxPs, GLPs, GCPs, USP/NF, ICH guidelines, EU regulations and other international agencies, scientific literature and other technical documents. • Responsible for the inventory and maintenance of Standard Operating Procedures (SOPs), Quality Unit Charters, protocols, checklists and other Intellectual Property documents • Supported the creation of effective regulatory and compliance training presentations • Managed support personnel to facilitate learning and accuracy within the databasereating,

• Pursued and obtained large volume sales orders• Coordinated manufacturing batches with production schedules and issued batch records

Performed various compliance adminstrative functions including working as a Government Account Specialist coordinating with US Depot locations for narcotics and other drug shipments.