LORI ALBERS

*** ******** **., *********, ** *****

Cell: 858-***-****

Career Summary:

Over 15 years’ experience in the software development life cycle

Extensive background in writing, executing, and reviewing requirements and test protocols

10 years’ experience in the medical field for software regulated by FDA, Health Canada, corporate standards, etc.

Proficient in Quality Center and IBM Rational

Proficient in writing SOPs to cover the entire SDLC to meet corporate standards as well as FDA guidelines

Technical Summary:

Quality Center, Rational ClearQuest, Rational Robot, Rational Requisite Pro, DOORS, Web testing, client/server testing, Unix (vi), SQL, Java, HTML/XML, Win NT, PeopleSoft, SNAGiT, Policy Administration System, PriceNow, Quote Management System, Guidewire

Regulatory Summary:

ISO 9001: 2000, ISO 13485, FDA 21 CFR Parts 11 and 820, Health Canada, and MDD (Medical Devices Directive) for the European Union

Experience:

PwC Columbia, SC (Insurance Software) 10/2016-6/2017

Test Case Writer (Contract Position through Randstad Technologies)

Duties: Translate technical data and concepts into actionable testing approaches. Implement enterprise initiatives on a large scale.

Work with client facing applications in collaboration with client service staff and involves recommendations for application optimization. Develop custom developed and packaged applications with exposure to all types of testing (Unit, System, Integration, Performance, Security, etc.). Experience in Agile and Waterfall. Work with offshore resources. Test management and analyze deliverables. Hands-on implementation across multiple technologies.

Utilized: Waterfall, Agile, SharePoint, HP Quality Center, MS Office, Policy Admin System, PriceNow, Quote Mngmt System, Guidewire (customized)

Blue Cross Blue Shield of South Carolina, Columbia, SC (Insurance Software) 09/2015 – 09/2016

Sr. System Test Analyst I (Contract Position through PSSI)

Duties: Lead, develop and execute Test Matrices for efforts involving large numbers of customers. Analyze functional requirements to determine software application testing requirements. Coordinate system testing and production implementation verification with I/S staff and Customer Testers. Assist with test planning and execution as needed. Oversee testing walkthroughs and JADS. Review I/S test results prior to customer testing. Ensure a complete testing matrix is in place by tracing requirements to test cases. Develop Test Plans. Facilitate effective communications with the customer during system and qualification testing, as well as help customers understand and resolve technical issues. Define and analyze quality assurance metrics such as defects, defect counts, test results, and test status. Lead process improvement initiatives related to testing methodologies and techniques. Make recommendations to clients on how to improve operational workflows.

Utilized: Waterfall, SharePoint, HP Quality Center, MS Office

AbbVie Inc., Waukegan, Illinois (Contract Position through Synectics) 07/2010 – 08/2015

01/2012 – 08/2015 Validation Software Facilitator – B (CR Management Software)

Duties: Participated in process mapping and departmental procedures. Prepared clear and concise system documentation, such as configuration documents. Document various processes. Review and update the Business Requirements Specification (BRS)/Functional Requirement Specification (FRS). Create training materials: job aids, training manuals by role, and work instructions by task. Workflow Analysis from business input. Use Case Development. Lead/support pre-release testing. Issues log management. Interact with software vendor for issue resolutions providing objective evidence. Testing and analysis performed for regression, performance, interface and legacy situations. UAT tasks – setup/update role matrix and software, report issues to vendor and schedule re-test. Software program includes 23 reports – responsible for testing, analysis, and issues resolution for all reports prior to release.

07/2010-12/2011 Validation Software Facilitator – B (Warehouse Management System)

Duties: Analyze test scripts for requirement coverage and test accuracy. Lead/support validation efforts and deliverables for projects requiring validation. Review newly created and executed validation test scripts and document test results in accordance with standards. Review and evaluate validation assessments for application systems/projects. Review/revise Validation Policy and SOP's as directed. File validation documentation within Quality Assurance Library guidelines. Create presentations.

Utilized: Waterfall, AGILE, VISIO, SharePoint, HP Quality Center, MS Office, SNAGiT, Java, PeopleSoft

Baxter Healthcare, Round Lake, Illinois (Medical Device) 10/2009-07/2010

Principal Quality Engineer – Testing (Contract Position through Aerotek)

Duties: Review DHF documents under the guidance of lead Program Quality Engineers. Provide guidance /mentorship/leadership for less experienced engineers. Support Quality Engineering in the review and approval for test cases, test plans and test reports. Communicate results, issues and seek to resolve those issues in a timely manner. Provide support in area of test case design, robustness and assuring compliance to procedures and standards.

Utilized: Waterfall, VISIO, SharePoint, HP Quality Center MS Office

Experience continued.:

eVenture Technologies, New Orleans, Louisiana (DIMHRS Project) 1/2007-10/2009

Systems Engineer – Requirements

Duties: Assure comprehensive requirement coverage. Manage and refine requirements. Ensure testability. Assist in translating from functional requirement to system capability. Work with multiple stakeholders to revise requirements for efficiency and effectiveness. Liaison between user and D & I contractor. Ensure data and functionality is synchronized to ensure customer satisfaction. Manage the testing process for twelve interfaces using XML and SQL. Liaison between D & I contractor and system owners. Work closely with D & I contractor to improve design quality. Keep management apprised of interface/testing issues and resolutions through CCB notification.

Utilized: Waterfall, VISIO, SharePoint, Rational Requisite Pro, MS Office, HTML/XML Page 2 of 2

Case Revolution, San Diego, California. (Insurance/Litigation Management System) 9/2005-3/2006

Lead Quality Assurance Engineer

Duties: Lead projects through the software development life cycle and the software test life cycle. Review requirement documents for accuracy, clarity, and requirement testability. Develop and implement software quality processes. Work closely with developers to improve design quality. Track defects for resolution through the software named Scarab. Review tests results and publish test reports. Select methods and techniques for obtaining solutions to quality software issues. Create test strategies and test cases. Create and perform detailed test procedures. Keep management apprised of product and external issues, which interfere with the team’s productivity or the integrity of the product. Execute software testing.

Utilized: Waterfall, MS Office

Sequenom, Inc., San Diego, California. (Bioinformatics) 4/2003-9/2005

Software Quality Engineer

Duties: Create Requirements/Risk Traceability Matrix. Perform GAP Analysis and create all related documentation. Perform Risk Analysis. Lead projects through the software development life cycle and the software test life cycle. Select methods and techniques for obtaining solutions to quality software issues by leading CCB discussions. Develop and implement software quality processes in accordance with ISO 9001: 2000, ISO 13485, and FDA 21 CFR Parts 11 and 820. Develop and implement an issue tracking system. Create test strategies and test cases. Create and perform detailed test procedures. Review tests results and publish test reports. Supervise temporary employee.

Utilized: Waterfall, Pro-Test, Rational ClearQuest, Rational Robot, MS Office, WinNT

HILL-ROM (A HILLENBRAND INDUSTRY), Cary, North Carolina. (Medical Device) 3/2001-2/2003

Design Assurance Engineer

Duties: Review requirement documents for accuracy, clarity, and requirement testability. Maintain awareness of FDA (21 CFR Part 820) and clinical requirements. Execute software testing - black box and gray box through using UNIX (vi). Maintain test equipment (ex. Physiological Monitors). Create test strategies and test cases. Create and perform detailed test procedures. Review tests results and publish test reports. Work closely with developers to improve design quality. Participate in design verification and validation planning. Keep management apprised of product and external issues, which interfere with the teams’ productivity or the integrity of the product. Review and implement SOPs and Work Instructions related to assignment areas and provide feedback for potential enhancements to the current processes.

Utilized: Waterfall, DOORS, MS Project, MS Office, Unix (vi), SQL

STRATEGIC ENERGY, L.L.C., Pittsburgh, Pennsylvania. (Energy Brokerage) 5/2000-2/2001

Quality Assurance Analyst

Duties: Resolve or escalate user issues. Execute software testing. Design, prepare, and update user documentation/training materials. Gather information from developers, users, and the overall product to provide accuracy in documentation. Evaluate software programs to verify validity per business requirements and functionality specifications. Analyze test results. Report code discrepancies. Develop test plans and test cases. Regression test from test plans and test cases to verify updates and bug fixes have not altered performance from previous test. Track defects for resolution. Work closely with developers on all aspects of Quality Assurance from design through final release. Find/help create a defect tracking system. Release new/updated software to the users.

Utilized: MS Office, SNAGiT

GENCO DISTRIBUTION SYSTEM, Blawnox, Pennsylvania. (Warehouse Software) 8/1999-4/2000

Quality Assurance/Trainer

Duties: Data check and validate test information through SQL and UNIX (vi) directly from the applicable server. Test client specific software. Provide software training for users and new employees. Work closely with development team in resolving software issues. Monitor and report system defects.

Utilized: SQL, MS Office

Education:

U.S.C. Coastal Carolina College, Conway, South Carolina

Received Bachelor of Arts, Major-History, Minor-English, Graduated May 1993

Security Clearance:

Eligibility Level: SECRET

Eligibility Granted: 20 Nov 2008

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