Margie Hoffman Email & Phone Number

Saint Louis, Missouri

• Generated data and participated in investigations into root cause of defects.
• Worked with Production and Process Engineering to create challenge samples for new automated equipment.
• Wrote and participated in experimental protocols to gather data in support of device design.
• Authored Compliance Analysis Status Report (CAS) for Product Technology department for the purpose of identifying areas of improvement in the initiative to bring the lab into cGMP compliance.
• Created various documentation including Technical Reports, Summary Report, SOPs and Job Aides.
• Responsible for bringing in new equipment such as X-ray, CMM and CT scanner. Wrote SOPs. Trained personnel and participated in validations.

Hudson, WI

Responsible for process improvement and new process development of plastic molded medical devices. Conduct engineering studies to develop process parameters for new medical devices and write Tech Reports.

Kansas City, Missouri Area

Development of precision cleaning methods for electro mechanical components. Responsible for cleanroom set up and implementation at a new facility.

Supervised the department responsible for formulating bulk parenteral drug in a cGMP environment. Department responsibilities also include cleaning and assembly of vessels, pumps and ancillary equipment used in the aseptic filling operations.Undertook projects designed to improve safety and efficiency.Created batch records and SOPs to meet manufacturing.

Managed automation assembly and packaging projects.Brought 2 major automated projects in house in an 18 month period.Worked extensively with production before, during and after the installation of the machines to ensure a smooth hand off.Held regular team meetings to communicate progress and identify issues.Wrote operating and maintenance procedures for.

Conducted studies and analyzed data for projects designed to improve quality.Managed project related tasks for a potential new drug product from batch record creation through formulation, filling and packaging.Coordinated interdepartmental activities to bring the projects to completion. Analyzed stability data and wrote research protocols and summary.

Assisted in research and selection of new methods. Responsible for method validation.Developed and executed IQ/OQ/PQs of new equipment.Responsible for the development of cleaning validation methods.Devised experiments and investigated impurities and degradants using HPLC and photodiode array detection.Responsible for the maintenance and calibration of lab.

Sample preparation, instrumental analysis and data generation of pharmaceutical products. Testing involved HPLC, TOC, UV-Vis, TLC, Karl Fischer, dissolution and raw materials/wet chemistry.Responsible for protocol, method and procedure development in the start up of a new lab. Responsible for equipment and method validations.Member of product development.

Tested pharmaceutical products and various chemicals in a cGMP lab. Testing involved HPLC, raw materials/wet chemistry, UV-Vis, IR, Karl Fischer and dissolution.Prepared client reports outlining results.Trained new personnel in lab policies and procedures.

Coordinated plant maintenance operations.Developed and implemented preventive maintenance program.Participated in safety inspections.

Bs/Chemeng, Chemical Engineering

Draftingcad Methods (Autocad)

Communication And Education Studies