732-***-**** Email: firstname.lastname@example.org
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.
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
Quality Center – Requirements, Test Plan, and Test Lab Modules
MS Office products – Excel, Word, Access, Visio and PowerPoint
System Software tested:
Clinical Trial Drug Management Software
Sales Order Entry and Distribution Software
Automated testing tools:
Original Software Test Bench, Test Director, Test Plan and Test Load
Client / Server
SQL (MS-SQL Server and DB2) used in validating test results
PECO – Company of Exelon Corporation
User Acceptance Tester February 2019 to Present
Contract Employee: American Cyber Systems, Inc.
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.
Software Testing Analyst June 2016 to February 2019
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.
System Documentation Specialist/Test Designer April 2015 to December 2015
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.
Tested software included CFR 21 Part 11 Components Electronic Signatures and Electronic Record
MSC Direct Industrial Supply December 2013 to December 2014
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