SUMMARY

A forward-thinking analyst with a superior knowledge of designing and executing validation packages including test procedures, test scripts and test strategy, for many different types of systems, including document management systems, embedded software and inventory tracking systems.

In addition, more than ten years, of first-hand experience, with all phases of the Software Development Lifecycle.

Highlights

Responsible for and built each deliverable in Validation Packages following the SDLC

Completed the validation of the BPCS inventory tracking software project, as Project Manager, Business Systems Analyst and Validation Lead, on time and under budget.

Known for writing efficient, maintainable and reusable protocols.

Proficient in requirements discovery and documentation

PROFESSIONAL EXPERIENCE

Dec 2017 – Present

Validation and Verification Engineer

Mortara Instruments – Milwaukee, WI

Responsible for equipment and process validation of health care products and delivering the following completed deliverables to build validation packages.

Validation Plan

Software Requirements Specification

Technical Document Specification

Validation Test Protocol

Validation Summary

Requirements Traceability Matrix

Worked with SME’s to obtain a clear understanding of instruments to develop and provide deliverables.

Worked across all departments, to meet milestones and deadlines, documenting testing procedures according to plans and deadlines.

Executed verification and validation reporting for all observed issues.

Communicated with departments to define, create and improve verification procedures/methods using all the related documentation.

Validation Packages included: DVTk RIS Emulator, DVTk Storage SCP, Smart HL7, Design Capture, Xpedition, Ansur Executive Fluke Biomedical, MicroStation PowerDraft, CorelDraw, ProcessMonitor, WhaleTeqSECG, WhaleTeqMECG

Jan 2016 – Nov 2017

Accountant / Bookkeeper / Analyst

Dustoff Inc. – Waukegan, IL

●Identify and measure transactions and other events

●Journalize transactions into the appropriate accounts in the General Journal.

Apr 2005 – Jan 2015

Software Validation Lead / Validation Analyst / Business Analyst / Project Manager

Abbott – Abbott Park, Illinois

I was part of a department, within Abbott, that outsourced resources, knowledgeable of the SDLC and an extensive knowledge of data integrity and regulatory requirements, to other departments within Abbott. Although we were full time employees of Abbott, hours were billed for the work we completed. Depending on the need of the client, my role at times included roles as a Validation Analyst, Business Systems Analyst, Validation Lead and for one project as a Project Manager. I worked often, in each capacity over the course of 10 years

●As a Software Validation Analyst,

●Evaluated and tested software programs and functional areas

●Drafted, reviewed, and executed test protocols based on functional requirement specifications for software validation work

●Developed and executed manual and automated scripts for requirement validation, integration, regression, performance and usability testing.

●Created and maintained reusable test data scripts.

●Participated in the creation of IQ/OQ and PQ phases

●Developed and issued software validation test reports.

●Followed testing strategies and recommended process and work improvements.

●Supported, organized and participated in technical design reviews, peer reviews, team meetings, and process audits.

●Experience with Process Validation, Cleaning Validation, Software Validation and Equipment Qualifications

Projects included the following: GDSN Solution, Password Manager, cApps, MKS RM TM, Pilgram, iQ (Matrix), sNap, PPD Sample Ordering v2,1, eECG/ABBIOS (Electronic Cardiogram/Abbott BioSignal), Phase I Management System (PIMS) 400, POMS (Production Operation Management System), Technology Engineering support, Data Center Server Room Consolidation (DCSRC), GDMS (Global Documentation Management System), eSubmissions, GDMS Dropdown List Data, Server Check v1.0 project, UNIX On Line Authorization v2.0 project.

●As a Business Systems Analyst,

●Followed the SDLC when developing URS’S and FRS’s to create detailed written user requirements

●Responsible for the approvals of User Requirement (URS) Specifications and Functional Requirements Specifications (FRS)

●BSA on an ISOtrain project

-Never missed agreed upon service level agreements (SLA’s).

-Opened, monitored and closed system issues within required timelines.

-Investigated re-occurring issues including making a case to move to the new version of ISOtrain to address one very visible, reoccurring issue.

-Escalated and followed up with higher tier problems to Softek.

●Assisted in the creation of risk assessments for many projects

●Gathered and documented business objectives, specifications and functional requirements.

●Often realized and recommended improvements to systems and processes

●Worked with US regulations (GMP parts 11, 58, 210, 211, and 820)

As a Software Validation Lead,

●Provided operational leadership and oversight in the successful delivery of testing services on several projects

●Able to quickly gain a detailed understanding of a process to optimize efficiencies, reduce cost, and improve quality

●Participated in internal audits

●Planned and conducted specification reviews, design assessments, and inspections of assigned software products and requirements.

●Designed, developed, and implemented software validation test strategies, test plans, and test procedures.

●Collaborated with IT Business Partners, Technical Team and other project stakeholders on Business Cases to provide estimates for testing services

●Planned and managed concurrent projects

●Key point of contact for all aspects of testing and coordinating resources.

●Lead and mentored full-time test team members, as well as managed outside contract testers.

●Monitored and tracked project status including incidents and resolution

●Assigned and tracked work assigned to the Testers

●Tracked and reported metrics against SLAs

●Managed and obtained resolutions for issues related to the testing and test environment

●Maintained a strong understanding of current IT trends, Cloud technologies, IT processes

Responsibilities include but not limited to: Create, Review, modify and approve SLC deliverables - Initiatives, URS/FRS, GxP Applicability Assessment, Application Risk Rationalization, Project/Validation Plan, Identification of Supporting System Documentation (ISSD), Configuration Item Inventory (CII), Installation and Deployment Plan (IDP), System Architecture Description, UAT Letter, Traceability Matrix, Results Review Report, System Certification Summary, Validation Test Protocols.

As a Project Manager,

●Managed the BPCS (iScala) inventory tracking system validation process in Bulgaria and Poland

●Worked with and managed a team of 5 testers. a BSA and an SQA in Bulgaria and Poland for the timely implementation of 23 new enhancements to iScala functionality

●Achieved zero production defects reported in the 1st week of implementation for both Poland and Bulgaria for the BPCS (iScala) project.

●Responsible for managing the creation, development and approval of each deliverable in the SDLC

Mar 2002 – Apr 2005

21 CFR Part 11 Compliance Lead

Abbott - Abbott Park, Illinois

●Inventoried and performed a gap analysis on all systems within ADD to assess them for Part 11 compliance

●Subject matter expert to execute 21 CFR Part 11 assessments and remediation for several ADD sites.

●Coordinated site assessments and remediation implementation project plans.

●Coordinated the development of site plans, budgets, and milestones for the site.

Apr 2000 – Mar 2002

Software Quality Assurance Analyst

Abbott – Abbott Park, Illinois

●Managed software validation, quality assurance, and technical writing services to Operations/QA and Commercial IM&T following the SQAP lifecycle. This was done through the review and approval of test data and supporting documentation to determine proper functionality of software applications.

Aug 1996 – Apr 2000

Business Systems Analyst

Hewitt Associates – Lincolnshire, IL

●Worked with the internal client teams and the developers to discover and record functional requirements.

●Developed, executed, and documented software test plans and results to ensure the quality of the software solutions.

●Frequently assigned to projects in the role of project manager. SQL and JCL were continually used. Included training in GUI, ADB2, QMF, CICS, batch concepts and mainframe tools.

EDUCATION

M. S. Finance and Accounting, 2012

Keller Graduate School of Management, Oak Brook, IL

Bachelor of Science in Economics, 1993

Washington State University, Pullman WA

CERTIFICATIONS

IIBA - ECBA Certificate in Business Analysis (June 2018)

Software Quality Engineer Certification – CSQE (May 2018)

Six Sigma Green Belt Certification - CSSGB

MicroShare Mar 2017

Masters Certificate Regulatory and Quality Compliance, 2007

Purdue University, W. Lafayette, IN

Masters Certificate in Information Systems, 2000

Keller Graduate School of Management, Oak Brook, IL

Software Skills

●QuickBooks Certification from Computer Training Source Inc.

●Fluent in the following Microsoft Office Products:

Microsoft Word

Microsoft Excel

Microsoft Powerpoint

●TOAD for Oracle

●SQL

●Facebook

●Twitter

●HP Quality Center

●SharePoint

ORGANIZATIONS

IIBA - International Institute of Business Analysis (Member)

ASQ – American Society for Quality (Member)

BDPA – Black Data Processors Association (Member)

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