comp.jobs.computers

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Job Title: Computer Validation Specialist
Job Location: PA: Phillipsburg
Pay Rate: Market
Job Length: full time
Start Date: 2008-02-22

Company Name: Thomas-Matthew Associates
Contact: Confidential
Phone: 267-756-7133
Fax: 267-756-7134

Description: Thomas-Matthew Associates, based out of Newtown, PA is a full service recruiting firm that specializes in providing individual attention to our clients and candidates.



Under the general supervision of the Director of IT Project Management, the Software Validation Specialist 2/3 will be responsible for assisting in the implementation of software systems in conformance with regulatory requirements as they pertain to CFR 21 Part 11 and Sarbanes Oxley. Further, candidate will be responsible for ensuring compliance with corporate initiatives and company standards as well as develop and maintain a comprehensive IT Quality Assurance Program in support of Medora’s pipeline. Responsibilities include establishing and/or overseeing IT QA program schedules, technical performance; preparing and implementing IT QA plans; performing IT QA reviews and audits to management. This includes, but is not limited to:



1. Assisting in the implementation of software, module by module, and ensuring systems function as intended.

2. Providing training as necessary for other members of the IT staff.

3. IT CAPA management.

4. Ensuring cost-effective compliance with quality standards.

5. Providing support for all IT functions associated with Quality.

6. Analyzing, defining, and documenting system requirements for data, workflow, logical processes, hardware and operating system environment, interfacing with other systems, internal and external checks, controls and outputs.

7. Writing and maintaining functional and technical specifications as well as other validation documentation as may be required.

8. Analyzing and estimating feasibility, cost, time, compatibility with other systems and computer capabilities.

9. Developing and maintaining plans outlining steps and timetables for developing, testing and installing applications.

10. Assisting to create test transactions and running tests to find errors and confirm program meeting specifications.

11. Consulting with supplier to prototype, refining, testing and debugging programs to attain CFR 21 Part 11 compliance/approval.

12. Writing and maintaining documentation to describe program development, logic, coding, testing, changes and corrections.

13. Writing documentation or reviewing documentation to describe program development, logic, coding, testing, changes and corrections.

14. Providing technical assistance, to the extent capable, by responding to inquiries regarding errors, problems or questions with programs.

15. Monitoring performance of programs after implementation.

16. Planning and preparing technical reports, memorandum and instructional manuals as documentation of program development.

17. Acting as departmental liaison between IT and Medaled Regulatory Compliance and Quality Assurance Department.

18. Assisting in other duties as necessary.



Required Skills

Bachelors Degree in Computer Science or equivalent work experience.



10+ years of testing and IT experience within a computing environment including experience creating new test-scripts and modifying existing test-scripts.



Effective analytical skills and ability to extrapolate information from written documents when information is missing, convoluted and/or unclear.



Effective verbal and written communication skills.



Ability to clearly document and report testing-effort results.



Ability to work independently or as part of a team in the resolution of problems and completion.



Strong organizational skills and ability to multitask.



Ability to work under the pressure of strict time-constraints and dynamic priorities.



Knowledge of ERP software operations and functioning, preferable People soft or SAP systems.



Knowledge of ISO-9001 Quality System, Certified Auditor preferred.



Knowledge of IT QA procedures and processes including acceptance testing procedures, defect tracking, benchmarking, process simplification and effectiveness improvement, customer satisfaction measurements.



Knowledge of software release management and software development life cycle processes. -Knowledge of software development and deployment processes.



If you are interested please submit your resume to Stephanie at sward@thomas-matthew.com.

Please refer to Job code 84mx85 when responding to this ad.


For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/1159535.html?source=ng to apply online.


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