David E. Hochman6105 Buchanan Street, Hollywood, FL 33024

Cell: 954.790.2334Email to: hochy33024@comcast.net

BackgroundExperienced professional offering knowledge and supervisory experience in the areas of Document Control, Change Control and Stability Program Coordination. Proficient in generating electronic revision controlled documentation in the operations department of a large MD&D (medical device and diagnostics company).

EducationBachelors Degree in Business AdministrationFlorida Metropolitan University, Ft. Lauderdale, FloridaGraduated October, 1998 Magna Cum Laude

Work ExperienceJanuary 2000 to September 30, 2016 Cordis Corporation, a Johnson & Johnson company, Miami, Florida**Cordis was purchased by Cardinal Health on October 3, 2016Documentation Specialist supporting Quality SystemsApplication Administrator for ADAPTIV PLM system.• Most recently worked in support of ADAPTIV (an Enovia Platform Product Lifecycle Management

System), Change and Document Control. Generate and disseminate ADAPTIV PLM reports reflecting overdue and coming due aspects using established metrics.

• Supported two product transfers to Mexico for Cordis Neurovascular. Was responsible for all documentation aspects of the transfer. This included change management of all documents, working with vendors to accept changes, working with translators to ensure translations are complete and working with engineers to support changes required as a result of transfer activities.

• Supported PTCA (Percutaneous Transluminal Coronary Angioplasty) Cardiac Balloon Procedure and Neurovascular Divisions.

• Supported the manufacture of Cardiology, Endovascular and Neurovascular products (Balloons, Catheters, Stents and Coil Delivery Systems).

• Responsibilities included electronic generation and revision of Cordis Manufacturing Routers, Work Instructions, Quality Work Instructions, Franchise Documents, Specifications, Validation Protocols, BOMs (Bills of Material), Drawings, Diagrams, Photographs and other controlled documentation.

September 1999 to December 1999Centeon Pharmaceuticals, Inc., Kankakee, Illinois Document Control Conversion Leader• Responsible for company's critical documentation conversion from WordPerfect 5.1 to Microsoft

Word 97.

July 1994 to February 1999 Andrx Pharmaceuticals, Inc., Fort Lauderdale, FloridaDocument Control Supervisor

• Start-up company involved in the development and manufacture of generic extended-release, solid, oral dose pharmaceutical products.)

• Administered the Change Control Program. Generated, proofed and edited reports, data and hard files consisting of company’s Master Batch and Packaging Records, SOPs (Standard Operating Procedures), STMs (Standard Test Methods) and Specifications.

• Maintained Raw Material files.

Stability Coordinator• Coordinated the initiation of product into Accelerated and Room Temperature environments. • Submitted the appropriate product samples for analyses on their scheduled days and entered the

resulting data into a specialized ScienTek Software program. • Generated stability reports for inclusion for ANDA (Abbreviated New Drug Applications) filings.

QA Auditor/Inspector• Conducted facility audits, maintaining FDA standards set forth by the cGMP (current Good

Manufacturing Practices) in anticipation of FDA inspections. • Performed room release inspections, product sampling, and batch record reviews.

Calibration Program Administrator• Maintained Master Equipment files using Blue Mountain Calibration Program software to track

calibration history of company’s equipment and instrumentation. • Assigned Asset/ID numbers. • Circulated notices of equipment calibration due dates to all departments concerned. Maintained the

database of the calibration records.

Work Related Classes• Two-day course on Batch Record Review and Investigations by PharmaNet, Inc. (October 1994)• Five-day seminar on Pharmaceutical Quality Assurance and Control by the Institute for Applied

Pharmaceutical Sciences (November 1996)

Computer SkillsWindows 7, MS Access, MS Word, MS Excel, MS Visio, Blue Mountain Calibration, ADAPTIV PLM System, ComplianceWire, cPDM (Collaborative Product Definition Management), IMAP (Information Mapping) Documentation and ScienTek Stability System software programs.