Professional Profile

Bryan Broedel is a highly skilled Professional with over 30 years experience as a Quality Manager, Quality Engineer, System Test Lead, Business Analyst, Regulatory Release Leader, Technical Writer and Computer Validation Specialist in the Pharmaceutical, Banking, Motor Vehicle Inspections & Enforcement, Automotive and IT Products & Services industries.

Bryan has extensive experience leading quality teams; developing and documenting standard operating procedures; gathering and documenting requirements; as well as writing, auditing and executing test and validation plans including System, User Acceptance, White-box, Black Box Testing; Installation, Operational and Performance Qualifications (IQ, OQ and PQ); Waterfall, Iterative and Agile Methodologies; and Automated Testing.

Education

MBA, Duke University

BS, Management Science, State University of New York College at Geneseo

Industries

Motor Vehicle, Inspections & Enforcement

Pharmaceutical, Clinical

Pharmaceutical, Manufacturing

Banking

Automotive, Manufacturing

IT Products & Services

Areas of Expertise

Software Quality Assurance

Regulatory Compliance – Part 11

Business Analysis

Computer Validation

Technical Writing

Experience and Skills

Selenium

VMWare / Oracle VM VirtualBox

Siperian Informatica MDM

Informatica PowerCenter

SAS DataFlux

HP Mercury Quality Center

HP Mercury Test Director

TFS, Jira

Top Team

Active Batch

Windows Command Line Scripting

Microsoft Virtual Machine

Micro Focus (Compuware) Test Partner

Compuware Reconcile

Compuware Track Record

Compuware QA Center

SQL Developer

SQL Query Analyzer

Hyperion Brio SQR Developer

Quest Toad

MS Visual Studio 6.0, 2005

MS Team Foundation Server

Microsoft Office, VB Macro

SQL Server

Oracle

Microsoft Access

DB2

HP-UX

PUTTY

Chronology of Experience

Opus Inspection [SysTech / ESP / Envirotest] Feb 2014 – April 2015

Industry: Motor Vehicle, Inspections & Enforcement Duration: 1 year

Position: Manager of Quality Assurance and Business Analysis

Environment: Web, Microsoft VB.NET, ASP.NET, SQL Server

Tools: TFS, Jira, Selenium; Microsoft: SQL Server Query Analyzer, Office 2010

Developed and implemented quality assurance and business analysis standards and processes applicable to all Opus Inspection software products delivered by the engineering department. Ensured engineering department compliance to minimum quality assurance testing and documentation standards as well as business analysis standards. Championed a quality culture within the engineering department.

Combined skillful diplomacy and firmness of commitment to coach and lead Opus Inspection in the direction of higher product quality deliveries. Interfaced with other department heads and senior management to educate and orient the organization toward a higher product quality commitment. Interfaced with Project Managers and participate in project management scheduling to ensure appropriate quality assurance and business analysis tasks are accounted for and scheduled in project plans.

Supervised quality assurance analysts, interns and business analysts. Supervised as well as performed hands-on quality assurance testing of software developed by the engineering department. Supervised as well as performed business analysis activities including requirements gathering, specification generation, and requirements communication.

Randstad Technologies (Opus Inspection) Sep 2013 – Jan 2014

Industry: Motor Vehicle / Inspections & Enforcement Duration: 4 months

Position: Quality Engineer

Environment: Web, Microsoft VB.NET, ASP.NET, SQL Server

Tools: Selenium; Microsoft: SQL Server Query Analyzer, Office 2010

Tested multi-tier vehicle inspection system to support North Carolina state vehicle inspection program and DMV law enforcement. Created and executed automated test scripts using Selenium IDE. Reported defects and prepared test results reports. Reverse-engineered baseline test requirements from specification and test documents.

Quintiles December 2006 – February 2013

Industry: Pharmaceutical, Clinical Duration: 6 years

Position: Systems Validation and Testing Lead

Sr. Systems Test Analyst

Environment: Windows NT & XP, SQL Server, IIS, Unix

Tools: MS Office, Lotus Notes, Test Director, Quality Center

Provided leadership with software quality control and computer system validation activities including: methodology; preparation; execution; and remediation. Serves as consultant to computer system users, developers and other groups in support of establishing and meeting quality objectives.

Prepared test protocols (scripts) and requirements specifications for internally and externally developed applications that support clinical business operations. Followed cGCP procedures. Maintained consideration for 21 CFR Part 11 and Sarbanes-Oxley Act. Prepared, executed and reviewed System Tests, User Acceptance Tests, Operation Qualification (OQ) and Performance Qualification (PQ) Tests. Utilized HP Mercury Quality Center, Test Director tools in preparation and testing of FDA regulated applications. Tested internally and externally developed applications according to approved validation protocols and test plans in an FDA regulated environment. Prepared validation reports for internally and externally developed applications according to approved operating procedures in a cGCP environment.

White-box & Black-box testing of Master Data Management (MDM) in Data Warehouse space [Informatica ETL, Dataflux, Active Batch]. Enterprise Document Management, Open Text, Livelink workflow solutions. Third party custom application, MS Enterprise Project Management Templates & Enterprise web Enhancements, Multi-tier SQL Server, C-based and Web Clients, Windows NT & XP. Third party custom application, Inventory Management, Client server Web - .Net, Windows NT. In-house developed, Document Management, Lotus Notes, Windows NT & XP. Validated Microsoft Visual SourceSafe, Custom Cold Fusion Web Applications, Interactive Voice Response (IVR), Hyperion Brio SQR Developer, Quest Toad.

Compuware May 2003 – December 2006

Industry: Automotive Manufacturing Duration: 3 years

Position: Quality Analyst, Technical Writer, Business Analyst

Environment: Microsoft VB.NET, ASP.NET, SQL Server

Tools: Compuware: QA Center, Test Partner, Reconcile, Track Record; Microsoft: SQL Server Query Analyzer, Office 2003

Tested in-house developed manufacturing quality traceability system. Created automated test scripts using TestPartner. Reported defects in TrackRecord. Prepared test results reports. Reverse-engineered baseline business requirements in Reconcile from design and test documents.

Industry: Banking

Position: Technical Writer, Business Analyst

Environment: Mainframe, z/OS, MVS, CICS, DB2, IMS

Tools: Quest 3270, MS Office

Reviewed and assessed business practices and technical specifications for data privacy initiative. Prepared analysis reports and implementation plans for data privacy solution. Prepared requirements specifications and supporting technical documentation for data privacy solution.

Industry: Pharmaceutical, Clinical

Position: Quality Analyst

Environment: Windows NT & XP, SQL Server, IIS, Unix

Tools: MS Office, Lotus Notes, Test Director

Provided leadership with software quality control and computer system validation activities including: methodology; preparation; execution; and remediation. Serves as consultant to computer system users, developers and other groups in support of establishing and meeting quality objectives.

Prepared test protocols (scripts) and requirements specifications for internally and externally developed applications that support clinical business operations. Followed cGCP procedures. Maintained consideration for 21 CFR Part 11 and Sarbanes-Oxley Act. Prepared, executed and reviewed Operation Qualification (OQ) and Performance Qualification (PQ) Tests. Utilized Mercury Test Director tool in preparation and testing of FDA regulated applications. Tested internally and externally developed applications according to approved validation protocols and test plans in an FDA regulated environment. Prepared validation reports for internally and externally developed applications according to approved operating procedures in a cGCP environment.

Enterprise Document Management, Open Text, Livelink workflow solutions. Third party custom application, MS Enterprise Project Management Templates & Enterprise web Enhancements, Multi-tier SQL Server, C-based and Web Clients, Windows NT & XP. Third party custom application, Inventory Management, Client server Web - .Net, Windows NT. In-house developed, Document Management, Lotus Notes, Windows NT & XP. Validated Microsoft Visual SourceSafe, Custom Cold Fusion Web Applications, Interactive Voice Response (IVR), Hyperion Brio SQR Developer, Quest Toad.

PharmaSys, Inc. August 2002 – May 2003

Industry: Pharmaceutical – Geneva, Merck, Schering-Plough Duration: 9 months

Position: Computer Validation Specialist

Environment: Windows NT & XP, SQL Server, IIS

Tools: MS Office, Lotus Notes, MS Outlook

Computer validation consultant to global pharmaceutical companies. Responsible for validation of entire SDLC including requirements, design, test/validation plans (IQ, OQ and PQ), etc. Audited computer systems and computer validation documentation for cGMP compliance, including 21 CFR Part 11. Prepared validation protocols and test plans for internally developed and COTS applications that support Manufacturing and Quality Assurance following cGMP procedures. Tested internally developed and COTS applications according to approved validation protocols and test plans in a cGMP environment. Prepared validation reports for internally developed and COTS applications according to approved operating procedures in a cGMP environment.

CompuVal, Inc. September 2001 - June 2002

Industry: Pharmaceutical – Bayer, Merck Duration: 9 months

Position: Computer Validation Specialist

Environment: NT, ISS, Oracle

Tools: MS Office

Independent computer validation consultant to global pharmaceutical companies. Prepared, executed and reviewed IQ, OQ and PQ Tests. Prepared validation protocols and test plans for internally developed and COTS applications that support Manufacturing and Quality Assurance following cGMP procedures. Test internally developed and COTS applications according to approved validation protocols and test plans in a cGMP environment. Prepared validation reports for internally developed and COTS applications according to approved operating procedures in a cGMP environment.

Kelly IT October 2000 - January 2001

Industry: IT Products/Services - Interpath Communications Duration: 3 months

Position: ASP Project Manager

Directed Web development team in creation of Vignette website for media industry business. Directed Internet application development and maintenance for banking industry clients. Tracked progress of project deliverables using MS Project. Prepared periodic financial reports and project plans for client and management review. Custom, Internet Client Server - SUN Solaris Unix, Windows NT, Oracle, SQL, Vignette, Perl.

Sapphire Technologies November 1999 - September 2000

Industry: State Government - NC DOT Duration: 10 months

Position: Business Analyst

Environment: MS Windows, PowerBuilder/Formula1

Tools: Ms Word, MS Excel, MS Project, SQA

Interviewed end-users and prepared requirements documentation for laboratory information system. Acted as liaison between end users and application development staff. Tested Power Builder/Formula1 client application. Reported test results using SQA tool. Maintained status of project progress using MS Project.

Enterprise Network Services of Virginia, Inc. April 1999 - August 1999

Industry: IT Products/Services Duration: 4 months

Position: Staff Consultant

Environment: OS/2, DB/2

Tools: MS Word, MS Excel, DB/2

Trained and managed consulting staff for deployment and operation of executive information system. Established customer service center to support operation of executive information system.

Bristol-Myers Squibb Company September 1983 - February 1999

Industry: Pharmaceutical, Manufacturing Duration: 15+ years

January 1994 - February 1999

Position: Technical Project Manager/Data Analyst & Modeler/Quality Engineer Duration: 5 years

Environment: HP 9000, MS Windows

Tools: HP-UX, Oracle, WordPerfect, Lotus 123, cc:Mail, CALS LabManager

Analyzed business processes, customer and user needs, and business opportunities in developing requirements of a Laboratory Information Management System (LIMS). Prepared Request for Proposal, solicited and evaluated vendor proposals, and facilitated selection of LIMS vendor. Assisted in planning, coordinating and performing activities in configuration, development, testing, validation, implementation and administration of Beckman CALS LabManager, a UNIX, Oracle based client/server LIMS. Developed and utilized UNIX and Oracle scripts to perform system administrative functions.

December 1991 - January 1994

Position: Group Leader, Regulatory Compliance Duration: 2 years

Environment: MS Windows, IBM RISC

Tools: IBM AIX, WordPerfect, Lotus 123, cc:Mail

Established Regulatory Batch Release Group and created SOPs for ongoing activities. Supervised up to 7 people in document review, material usage reconciliation records management, and finished product release. Analyzed business requirements for Document Imaging System and prepared the RFP. Directed activities in development and implementation of a Document Imaging System. Prepared and executed computer system validation of a Document Imaging System. Facilitated TQM changes, value added analysis, benchmarking, production and release cycle time reduction, and computer system validation.

December 1989 – December 1991

Position: Data Systems Administrator Duration: 2 years

Environment: Wang OIS, OS/2

Tools: OS/2, Lotus 123, Multimate, Wang Document Management, R:Base

Administered and maintained document control and laboratory PC computing systems. Evaluated and implemented new computing technologies for use in the Quality Control laboratory. Coordinated revisions, approvals and issuance of production and control documents with Manufacturing and Quality Control staff.

June 1987 - December 1989

Position: Analytical Technician Duration: 2 years

Collected samples of Raw Materials for Analytical and Microbiological testing following cGMP procedures. Tested Raw Material and In-process samples for Quality following GLP procedures. Maintained appropriate documentation in performing sampling and testing procedures in following cGMP and GLP procedures.

September 1983 - June 1987

Position: Finisher/Backup Supervisor Duration: 4 years

Supervised Finishers in the operation of packaging equipment in finishing operations of solid dosage products following cGMP procedures. Prepared standard operating procedures (SOPs) and training procedures for packaging operations following cGMP guidelines. Trained new employees on the operation of packaging equipment in finishing operations of solid dosage products following cGMP procedures. Operated packaging equipment in finishing operations of solid dosage products following cGMP procedures. Maintained appropriate documentation in performing sampling and testing procedures in following cGMP procedures.

Experience Highlights

Manager of Software Quality and Business Analysis – Opus Inspection – Developed and implemented quality assurance and business analysis standards and processes applicable to all Opus Inspection software products delivered by the engineering department. Ensured engineering department compliance to minimum quality assurance testing and documentation standards as well as business analysis standards. Championed a quality culture within the engineering department.

Combined skillful diplomacy and firmness of commitment to coach and lead Opus Inspection in the direction of higher product quality deliveries. Interfaced with other department heads and senior management to educate and orient the organization toward a higher product quality commitment. Interfaced with Project Managers and participate in project management scheduling to ensure appropriate quality assurance and business analysis tasks are accounted for and scheduled in project plans.

Supervised quality assurance analysts, interns and business analysts. Supervised as well as performed hands-on quality assurance testing of software developed by the engineering department. Supervised as well as performed business analysis activities including requirements gathering, specification generation, and requirements communication.

Systems Validation and Testing Lead – Quintiles

Sr. Systems Test Analyst – Quintiles

Quality Analyst – Quintiles & Compuware Corporation – Provided leadership with software quality control and computer system validation activities including: methodology; preparation; execution; and remediation. Serves as consultant to computer system users, developers and other groups in support of establishing and meeting quality objectives.

Prepared test protocols (scripts) and requirements specifications for internally and externally developed applications that support clinical business operations. Followed cGCP procedures. Maintained consideration for 21 CFR Part 11 and Sarbanes-Oxley Act. Prepared, executed and reviewed System Tests, User Acceptance Tests, Operation Qualification (OQ) and Performance Qualification (PQ) Tests. Utilized HP Mercury Test Director tool in preparation and testing of FDA regulated applications. Tested internally and externally developed applications according to approved validation protocols and test plans in an FDA regulated environment. Prepared validation reports for internally and externally developed applications according to approved operating procedures in a cGCP environment.

White-box & Black-box testing of Master Data Management (MDM) in Data Warehouse space. Enterprise Document Management, Open Text, Livelink workflow solutions. Third party custom application, MS Enterprise Project Management Templates & Enterprise web Enhancements, Multi-tier SQL Server, C-based and Web Clients, Windows NT & XP. Third party custom application, Inventory Management, Client server Web - .Net, Windows NT. In-house developed, Document Management, Lotus Notes, Windows NT & XP. Validated Microsoft Visual SourceSafe, Custom Cold Fusion Web Applications, Interactive Voice Response (IVR), Hyperion Brio SQR Developer, Quest Toad.

Quality Analyst – Compuware Corporation - Takata – Tested in-house developed manufacturing quality traceability system. Created automated test scripts using TestPartner. Reported defects in TrackRecord. Prepared test results reports

Business Analyst – Compuware Corporation - Bank of America – Reviewed and assessed business practices and technical specifications for data privacy initiative. Prepared analysis reports and implementation plans for data privacy solution. Prepared requirements specifications and supporting technical documentation for data privacy solution.

Computer Validation Specialist – PharmaSys, Inc. – Computer validation consultant to global pharmaceutical companies. Responsible for validation of entire SDLC including requirements, design, test/validation plans (IQ, OQ and PQ), etc. Audited computer systems and computer validation documentation for cGMP compliance, including 21 CFR Part 11. Prepared validation protocols and test plans for internally developed and COTS applications that support Manufacturing and Quality Assurance following cGMP procedures. Tested internally developed and COTS applications according to approved validation protocols and test plans in a cGMP environment. Prepared validation reports for internally developed and COTS applications according to approved operating procedures in a cGMP environment.

Computer Validation Specialist – CompuVal, Inc. – Independent computer validation consultant to global pharmaceutical companies. Prepared, executed and reviewed IQ, OQ and PQ Tests. Prepared validation protocols and test plans for internally developed and COTS applications that support Manufacturing and Quality Assurance following cGMP procedures. Test internally developed and COTS applications according to approved validation protocols and test plans in a cGMP environment. Prepared validation reports for internally developed and COTS applications according to approved operating procedures in a cGMP environment

Project Manager – Kelly IT – Directed Web development team in creation of Vignette website for media industry business. Directed Internet application development and maintenance for banking industry clients. Tracked progress of project deliverables using MS Project. Prepared periodic financial reports and project plans for client and management review. Custom, Internet Client Server - SUN Solaris Unix, Windows NT, Oracle, SQL, Vignette, Perl.

Professional Education and Training

Languages

SAS Fundamentals: A Programming Approach, SAS Institute

FORTRAN 77

COBOL

APL

SPSS

FOCAL

BASIC

Assembler:

COMPASS

INTEL 8085

Databases

Introduction to Oracle: SQL and SQL*Plus, Oracle Corp.

Develop Complex Data Models and Design Databases, Oracle Corp.

Oracle 7 Database Administration, Oracle Corp.

Beginning R:Base 3.1, Executrain

Operating Systems

Intermediate Windows 3.1, Executrain

UNIX System Basics I, Hewlett Packard

HP-UX 10.0 System Administration for HP 9000, Hewlett Packard

IBM AIX

Sun Solaris

Introduction to Novell 3.11, Executrain

Novell 3.11: System Administration, Executrain

Tools

Quality Center 9.x, HP Mercury Interactive

Test Director 7.6, Mercury Interactive

Test Partner, Compuware Corp.

Other

Project Management Certificate Program, International Institute for Learning

Beckman CALS, Introduction to CALS LabManager, Beckman Instruments

Beckman CALS, Advanced LabManager, RGEN & SCRMP, Beckman Instruments

Beckman CALS, LabManager System Administrator, Beckman Instruments

Beckman CALS, LabManager LIMSBuilder, Beckman Instruments

Beckman CALS, LIL/Instrument Data Acquisition System, Beckman Instruments

MS Office

MS Project

Lotus 123 f/Windows 4.0, Beginning Worksheet, Executrain

Lotus 123 f/Windows 4.0, Advanced Spreadsheets, Executrain

Procedures Author, POMS, INCODE Corp.

Skills

Languages

MS VB 6

MS Office VB Macro

SAS

HP-UX Scripting

DOS Scripting

Databases

SQL Server

Oracle

MS Access

DB2

R:Base

Operating Systems

MS-DOS

MS Windows (95, 98, NT, 2000, XP)

OS/2

Novell

AIX

HP-UX

Data Warehouse Environment

Siperian Informatica MDM

Informatica PowerCenter

SAS Dataflux

Active Batch

Tools

Test Director

TestPartner

Reconcile

TrackRecord

QA Center

Quality Center

SQL Developer

SQL Query Analyzer

Hyperion Brio SQR Developer

Quest Toad

MS SourceSafe

PUTTY

Team Foundation Server

Visual Studio 6.0, 2005

Hardware

Intel i86

IBM RISC

HP 9000

Contact this candidate