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Robert Weiss

Philadelphia, Pennsylvania, United States
August 20, 2019

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Robert Weiss

**** ****** ****** ************, ** 19115

732-***-**** Email:

Provide Quality Assurance, Computer System Validation, and user documentation in a regulated Software Development environment. Industry experience includes clinical trial and manufacturing pharmaceutical, apparel, utilities, MRO sales and distribution, and discrete and process manufacturing.

Core Competencies

Write clear and concise test plans, test cases and test scripts

Experience with QA testing and User Acceptance Testing

Analysis and writer of Business, User and Functional Requirements

Development of Requirements to test script Matrix

Experience leading/training junior testers

Author of End User Documentation, Training Documentation and Job Aids

Experience in Waterfall and Agile methodologies

Software/System Knowledge

Software Applications:


Microsoft VSTS

Clear Quest


Master Control

Quality Center – Requirements, Test Plan, and Test Lab Modules

MS Office products – Excel, Word, Access, Visio and PowerPoint



Team Track

System Software tested:

Clinical Trial Drug Management Software


Sales Order Entry and Distribution Software

Tested web browser-based software programmed in JavaScript and .net, and web sphere Java with RPG on AS400

Methodology Experience



Automated testing tools:

Original Software Test Bench, Test Director, Test Plan and Test Load



Client / Server

Computer Languages:

SQL (MS-SQL Server and DB2) used in validating test results



PECO – Company of Exelon Corporation

Philadelphia, PA

User Acceptance Tester February 2019 to Present

Contract Employee: American Cyber Systems, Inc.

Responsible for:

Write and execute Test Cases for projects used by PECO customers on the PECO website, including a Solar Calculator evaluator program for evaluation of installation of solar panels on customer rooftop property. Tested secure website all browsers, mobile devices and apps. Tested text message outage notification system.

Almac Group

Lansdale, PA

Software Testing Analyst June 2016 to February 2019

Responsible for:

Test Clinical Trial Study Drug Management Software. Projects include both new studies and maintenance amendments per User Requirements and Specifications. Product manages drug assignment for Clinical Trial subjects participating in Clinical Trials. Product includes double blinded, blinded and open label studies. Tested product is GCP and CFR 21 Part 11 Compliant.


Newtown, PA

System Documentation Specialist/Test Designer April 2015 to December 2015

Responsible for:

Writing and updating Design Specification documents containing Product Requirements and Functional Design Specifications, department SOP’s, client validation documents, trace matrixes for Pharmaceutical and Medical Device Clinical Trial Submission software for both US and EU Clinical Trial submissions.

Writing test (scripts) cases for both System Testing and Client Acceptance Testing.

Testing and logging bugs discovered during usage in applications in Test Environment for applications programmed to use multiple web browser utilizing C#, XML and JavaScript programming languages. Also, used MS ̵SQL to create SQL queries from the test environment.

Tested software included CFR 21 Part 11 Components Electronic Signatures and Electronic Record

MSC Direct Industrial Supply December 2013 to December 2014

Melville, NY

Contractor, Mondo

Sr. QA tester

Test bug fixes and enhancements for Warehouse and Sales order fulfillment application on AS400. Use DB2 SQL, DB Visualizer and HP Quality Center to write test cases and steps, run tests, and log defects. Software includes distribution and warehouse shipping functionality. Testing includes interfaces to supporting systems. Wrote test scripts for SAP EHS custom forms and programs in phase 2 of the SAP EHS implementation.

Janssen Pharmaceutical, a J&J Company January 2013 to March 2013,

June 2013 to Sept. 2013

Contractor, C&G Consulting

Sr. Computer System Validation (CSV) Tester

Executed and wrote Validation test scripts for fixes, enhancements and data migration to Docspace, a customized Documentum system. Wrote and executed test scripts. Functionality includes CFR 21 Part 11 Electronic signature and Electronic Record compliance components. HPQC modules Requirements, Test Plan, and Test Lab were used for requirements mapping, test development and test execution.

PFIZER, INC., Collegeville, PA January 2012 to December 2012

Consultant from Tata Consultant Services (TCS)

Sr. QA Validation Analyst

Responsible for quality assurance review of test scripts in Quality Center, new requirements/ functional specifications, and technical design specification documents, as well as ensuring traceability for the SAP ERP project.

Responsible for rewriting functional specifications in the SMART (Specific, Measurable, Achievable, Realistic and Testable) format, while matching requirements to the Business Process map in ARIS for manufacturing business requirements for Pfizer’s SAP system.

PFIZER, INC., Peapack, NJ January 2001 to December 2010

Contractor from Essential Data

Quality Assurance/Computer System Validation Analyst

Responsible for testing and maintaining the quality of Pfizer’s in-house developed ERP system, MAPS (Manufacturing Accounting Planning System), and interfaces to Supply Chain and LIMS systems.

Maintained and developed test plans and Commissioning (pre-validation) test protocols for major enhancements and minor changes to the system. Responsible for testing major releases, incremental releases and fixes due to bugs and providing test evidence for tested components. Test plans and protocols were for cGMP and non-cGMP functions, in adherence to FDA cGMP regulations. Testing adhered to SDLC specific SOPs. Functionality included CFR 21 Part 11 Electronic signature Electronic Record compliance components. Software was developed on an AS400 with various functions (Java based) available with web browser.

Experienced with core Installation Qualification (IQ) / Operational Qualification (OQ) process / Validation User Acceptance Testing (UAT) through editing of validation test scripts. Regularly trained in departmental and corporate SOPs, general cGMP and GDP. Knowledgeable in CFR 210 and CFR 211 and CSV Risk Analysis.

Unilaterally developed complete Load test for multi-functional (30 transactional and inquiry scripts), multi-user (600 simultaneous users) test. Testing experience includes automotive testing tool TestBench, TestDrive and TestLoad (Original software). See Training.

Helped developers, users at pharmaceutical manufacturing plants worldwide, help desk coordinator and implementers with answers and investigations into functional area problems and questions.

Provided response to requests (without further requests) from FDA and other government regulatory agencies made to Pfizer plants for evidence of testing from executed test scripts based on questions by government agency inspectors.

Led and trained an offshore team of 4 quality assurance testers located in Chennai, India in developing manual and automated scripts. Supervised and edited a Traceability matrix tracing system business requirements with existing test scripts.

ORACLE CORPORATION, Tarrytown, NY November 1999 to October 2000

Senior Technical Writer

Wrote user guides for manufacturing applications software titled Oracle Process Manufacturing. Responsibilities included maintenance of the following user guides: OPM Order Fulfillment, Regulatory Management, Purchase Management, Production Management, Process Operations Control, Using Oracle Order Management with Process Inventory, and Advanced Planning Scheduling. Responsible for providing text for Release Notes for all versions of OPM releases.


Temple University Philadelphia, PA

BA in Communications Major: Journalism

Spring Garden College Philadelphia, PA

Major: Computer Engineering Technology

Completed 87 credits toward BS in Computer Engineering Technology

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