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RssSenior Consultant, Leader experienced in Quality, Validation and Testing in a regulated industry.

I am seeking an opportunity to apply years of experience and best practices in a quality, computer systems validation, testing role. My experience allow me the versatility of requirements gathering, and operating as a liaison between business and technical teams. I have managed quality teams on a number of projects, and tend to see the big picture for client relations management.

Quality Assurance Specialist

Indianapolis, IN

About Me

Industry:

Information Technology

Occupation:

Quality Assurance Specialist

Ideal Companies:

Lilly Pharmaceutical, Roche, Rolls Royce, Allison, Chase,
 

Education level:

Bachelor

Will Relocate:

No

Location:

Indianapolis, IN

Work Experiences

11/2007 - Present

(private)

Individual Contributor

  • Quality Coordinator Test Coordinator Validation Lead Consultant for two Computer System Validation and Testing projects at Lilly Pharmaceutical. Quality role to ensure compliance and usability for new Seibel Client Relation Management and Reporting system featuring Account Management and Access Control in Regulated Environment. Supports project stabilization and maintenance within the Center of Excellence for several regulated and non-regulated systems. Change management, quality and systems testing oversight on Siebel, telephony, and contact management systems.

10/2002 - 7/2007

CTG, Inc

Contractor / Freelance

  • CTG, Inc. Indianapolis, IN Validation Engineer Sr. Consultant managed teams of Consultants in roles in Computer Systems Testing and Validation, Quality Analyst, and Communications Analyst. Lead roles included project resource management, client relationship management, process improvement, methodology and process development and business development. Completed validation and testing deliverables for the following client companies: Lilly Pharmaceutical Company Sr. Validation Analyst (04/2007 – 07/2007) Conducted Computer System Validation periodic reviews, and created computer system validation packages for small systems managed by Lilly's Drug Disposition team. • Audited approved computer system validation packages. • Conducted gap analysis to identify impact of updated regulatory policies and procedures. • Recommended corrective action plans. • Developed test plans and test scripts. Johnson & Johnson Pharmaceutical Company Test Analyst (2/2007 – 4/2007) • Drafted and update test scripts. • Prepared test scripts for test execution. • Performed quality review of test scripts. Lilly Pharmaceutical Company Service Delivery Coordinator (01/2004 – 02/2007) On-site for Global Manufacturing & Engineering IT team to manage Computer System Validation resources. Position includes client relations management, team lead, project management, and preliminary contract negotiations. Key Business Accomplishments: • Active role in securing $1.1 million renewable contract. • Managed team of resources on 12 system validation initiatives. • Developed model for deliverables based solutions. • Trained and developed new employees. • Developed Solution Delivery process. • Defined Escalation Model. • Performed Financial Analysis. Key Quality/Testing Accomplishments: • Interim Test Lead • Gathered system and business requirements. • Developed test plans. • Reviewed test plans. • Performed quality analysis of test data. • Reviewed system test scripts. • Reviewed test results. • Created test summary reports. • Reviewed and escalated defects. • Developed or modified test scripts. • Executed test scripts. • Completed test summary reports. • Completed periodic review reports.

Education

1999

Certification Degree

Ivy Tech

  • Novell Network Adminstrator

1985

Bachelor Degree

University of Illinois

  • Marketing

Keywords