Sales Manufacturing

Profile

As a Technical Writer/Documentation Specialist/Compliance Analyst with more

than 20 years of relevant experience for commercial and government clients,

I have created installation, operation, and maintenance manuals; software

user manuals; health and safety procedures; marketing literature; business

system procedures; and technical proposals. As a consultant, I have

successfully worked with a full range of subject matter experts including

top-level managers, engineers, manufacturing personnel, and marketing and

sales professionals; as well as specialists in varied disciplines including

geology, physics, computer hardware/software, and computer security.

Standards and regulations with which I have experience include ISO, SOX,

HIPAA, SAS-70, FDA, NRC (Nuclear), and CERCLA/RCRA (Environmental). Most

recently I ushered a major financial institution through a computer

security audit for successful certification by the Payment Card Industry

(PCI).

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Professional Experience

Manufacturing Industry - ISO/QS 9000 Technical Writer and Business Analyst

Kellogg Co / Keebler Snacks, Cincinnati, Ohio 1/2010 to 4/2010

. Short-term contract to construct Troubleshooting Guides with heavy

graphic and visual content to be used in conjunction with SOPs on the

manufacturing floor for Keebler products. Guides covered the full

"line" from formulation mixing, cutting, baking, packaging,

shrinkwrapping, and palletizing.

Makino, Mason, Ohio 2000 to 2001; and 2002 to 2003; and 2008

. As part of a two-member team, helped to plan, document, and implement the

ISO 9000 Business Quality System for a mid-size manufacturing company.

. Analyzed business processes and business applications to create maximum

efficiencies.

. Reviewed, analyzed, and evaluated processes and procedures to recommend

ways to streamline and modernize.

. Interfaced with top and mid-level management to plan and document process

flows that met good manufacturing practices for ISO certification in a

machining industry that supports strict automotive industry standards.

. Worked with manufacturing, engineering, IT, and office personnel to

produce support documentation including standard operating procedures,

work instructions, forms, and databases.

. Prepared internal audit materials to meet external audit standards for

all sectors of the corporate quality system.

. Created electronic documentation and data control, retrieval, and

archival functions using advanced features of Microsoft Word, Access,

Visio, Intra.Doc, and other standard software packages and databases.

. Prepared for ISO/QS audit by performing gap analyses for each department

and verifying all employees were trained and familiar with the approved

documents and processes.

. Returned several times to review, update and expand documents for ISO

audit requirements.

Financial Industry - IT Computer Security - PCI Docmentation Specialist -

Compliance Analyst

Resurgent Capital Services, Cincinnati, Ohio 2006 - 2009

. Assumed full responsibility for writing all computer security procedural

documentation required to meet Payment Card Industry (PCI) certification.

. Reported directly to the CSO and two corporate VPs for this time critical

project.

. Working from the Visa Data Security Standard (DSS), wrote and organized

more than 150 documents used to audit computer and data security

processes.

. Worked with a team to infiltrate and adjust the IT governance and

corporate culture in preparation for the audit. Efforts included

security training, risk management, records retention/deletion, and

incident response procedures.

. Created an electronic library to store and access all of the documents.

. The company passed the audit and was granted PCI certification.

Successful certification opened the door to a wide range of new contract

possibilities.

. Third party auditors commented that the "documentation effort was the

best" they had ever seen.

. Started from 'scratch' to develop a Disaster Response and Contingency

Planning program.

. Fully documented all DR/BC procedures for this effort including templates

used to document database application and server recovery, server

hardening process, and logistical process for establishing a command

center and contingency operations.

Fidelity Investments, Covington, Kentucky 1999

. Documented Oracle-based enterprise resource planning (ERP) system

software for major production/mass-mail facility.

. Documentation efforts involved detailed procedures for ERP modules

including engineering, manufacturing, material handling and inventory

control, process flow and documentation, forecast and material planning,

etc.

. From process flow diagrams, personal interviews, and historic

documentation, gathered requisites and created a full set of procedures

that are used for internal staff training as well as to satisfy Security

and Exchange Commission requirements for timely delivery of client

investment information.

. All work was accomplished using advanced features of Microsoft Word

including graphic import, drawing capabilities, color highlighting,

tables, form, and other enhancement capabilities.

Retail Industry - Contract Technical Writer and Analyst

Kroger, Cincinnati, Ohio and Sara Lee, Cincinnati, Ohio 2003 - 2006

. Prepared on-line and hard copy of documentation for web-based

applications.

. Wrote use cases and test plans to meet guidelines of Rational Unified

Process (RUP) and Software Delivery Process (SDP).

. Tested software; researched, reported and tracked issues/audit

exceptions; re-tested and approved fixes.

. Assumed project management responsibilities for team during absence of

PM. Acted as liaison between corporate users and software

engineers/developers.

. Wrote procedures and other required documentation for Sarbanes Oxley

(SOX) audit including IT and network security controls, mainframe

security procedures, and software security validation and verification.

. Wrote test plans, conducted pre-testing, documented findings, and

published remediation plans.

Pharmaceutical Industry - Contract Technical Writer

Eli Lilly, Indianapolis, Indiana and Ethicon Endo-Surgery, Blue Ash, Ohio

2001 - 2003

. Responding to U.S. Food and Drug Administration (FDA) audit, 483, and

warning letter, worked with international team of engineers and

scientists to address non-compliance issues including computer system

validation, installation/operation qualifications (IQ/OQ), current Good

Manufacturing Practices (cGMP), data storage/retrieval, change control,

and training.

. Created procedural documentation for capsule filling, tablet press, and

packaging machinery.

. Following FDA guidelines and requirements, responded to user complaints

and inquiries regarding product safety.

Environmental Industry - Proposal Center Coordinator, Staff Supervisor, and

Technical Writer

IT Corporation Environmental Consultants, 1995 - 1998

. Coordinated all aspects of commercial and government proposal writing

including SF 254/255 responses.

. Directed and managed proposal-writing efforts and activities of subject

matter experts, writers, clerical support, contract administrators, cost

estimators, subcontractors, and graphic designers.

. Researched client background, regulatory status, requests for proposal

(RFPs) Commerce Business Daily (CBD) announcements, and subcontractor

requirements in support of business development and marketing

communications.

. Developed, created, and produced statements of qualifications (SOQs),

newsletters, marketing and sales brochures, oral presentations, booths

and displays.

. Translated technical and scientific environmental information into user-

friendly documents, brochures, and publications.

Manufacturing Industry - Technical Writer/Documentation Specialists/QA

Ronan Engineering Corporation, Florence, Kentucky 1994 - 1995 and Ohmart

Corporation, Cincinnati, OH 1987-1992

. Researched, developed, and implemented best methods, format, style, and

procedures for producing user manuals, sales literature, manufacturing

procedures, and other ISO 9000 required documentation.

. Using desktop publishing software, integrated graphics with text to write

and publish installation/operation manuals, maintenance procedures, and

other technical documentation for nuclear sensor measurement systems,

process-control instrumentation, and radiological safety, including

10CFR19, 20, and 30.

. Developed and implemented ISO 9000 approved strategy, including

computerized database, to ensure correct user documentation accompanied

each product when shipped.

. Facilitated internal flow of technical information among engineering,

sales, and manufacturing departments.

Graduate Intern/Graduate Research Assistant 1992 - 1994

. Technical Writer, Fernald Environmental Management Corporation.

Organized, wrote and edited Environmental Safety & Health procedures to

Department of Energy (DOE) format and style. Researched DOE procedure

content requirements, and worked with subject matter experts and field

technicians to ensure technical accuracy and consistency with NEPA,

CERCLA, and RCRA requirements. Fulfilled thesis requirements to complete

graduate work in Environmental Communications.

. Graduate Research Assistant, Miami University. Assisted two sociology

professors with research, study, and publication of "Public Science

Literacy and Knowledge-Based Risk Perception" for a Department of Energy

(DOE) and Fernald Environmental Management Corporation grant. Efforts

included personal interviews; research of technical publications and

databases; analysis of community meetings and interactions of population

segments; and evaluation of the historic DOE culture and legacy of

secrecy extending from the weapons production days of the Cold-War era.

Credentials

. M.En, Environmental Science, The Miami University, Oxford, OH

. B.A., Psychology, Waynesburg College, Waynesburg, PA

. A.S., Design and Drafting Technology, Allegheny County Community

College, PA

. Certified Technical Writer, Graduate Level, Wright State University,

OH

. Certified Radiation Worker, Cincinnati, OH

. ISO/QS9000/TE Supplemental Internal Quality Audit Training

. CGMP and CSVP Training, Eli Lilly Pharmaceutical

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