Mark Silver Email & Phone Number

United States

Princeton, New Jersey

Boston, Massachusetts

Houston, Texas

Responsible for control of Quality System documentation under specific FDA guidelines. Supported maintenance of the Quality Document Center, Ensured that processes and procedures were followed. Provided support to management during regulatory inspections. Trained new staff on Good Documentation Practices (GDP).

Warsaw, Indiana

Document Control Manager in medical device industry. Managed staff of document controllers handling all corporate documentation.Coordinated distribution of Corporate QMS and non-QMS documents to global sites.Developed Document Control Governance.Adapted document control processes to new ECM structure.Generated multiple daily and weekly reports.Maintained.

Houston, Texas

• Project lead for the Americas on a global business process transformation and technology solutions evaluation program focused on document and records management for FMC’s subsea business unit using Open Text as.
• Led project efforts to identify and document current state process and workflows
• Facilitated and led “discovery” meetings with multiple stakeholder groups to identify all document types, and categories, and document the associated policies, procedures, and workflows
• Collaborated with other project leads to identify process/workflow commonality and exceptions as dictated by geographic requirements. Ensured consistency of project activities and deliverables
• Performed analysis of existing systems to identify gaps in business processes and enhanced business processes to align with system functionality and configuration
• Project deliverables developed included: process and workflow diagrams with swim lanes (Visio), procedures, business requirements, dependency matrices, and document control standards

Houston, Texas

Brought in as contractor through Oce Business Services.Responsible for all FEED and EPC topside and subsea projects in Chad, Cameroon and Equatorial Guinea (MEGI), including Zafiro and Ekanga.Wrote process for handovers and created supporting documentationWorked with local contractors and vendors on document control procedures, document numbering, MDR..

Fort Lauderdale, Florida

Family consulting business. Helped to resolve outstanding issues and windup business.

Houston, Texas

Evaluated all available software programs to implement document control and invoice workflow processImplemented new EDMS - pVaultCreated software training manuals for use by employeesEstablished and presented live and digital training for all employeesFacilitated system migration of Sage Timberline to new server with SQL server 2008Responsible for.

Juris Doctorate (J.D.)

Bachelor Of Science (B.S.)