QA - Biotech Resume Search
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QA Resume


Desired Industry: Biotech SpiderID: 22359
Desired Job Location: Corvallis, Oregon Date Posted: 8/29/2008
Type of Position: Full-Time Permanent Availability Date: 9/1/08
Desired Wage: 90,000
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Bachelors Willing to Relocate: Yes


Objective:
Over ten years of testing, QA, V&V and CSV experience.
Extensive understanding of QA as it applies to all phases of the development life cycle, including design verification, validation and acceptance testing. I am experienced developing strategic test plans, test cases/protocols and scripts and assuring that the system requirements are properly specified and have been satisfied, interfacing with various departments and vendors as required. I have performed testing products using black box, end-to-end and ad-hoc techniques. Knowledgeable and skilled in software QA testing: regression testing (both system and bug), acceptance testing, compatibility testing, system testing, functional testing, verification and validation, GUI and Internet testing. I enjoy working with biotech and medical projects, having successfully tested and qualified class 1 & 2 devices, complying with FDA (CFR) and ISO regulations. I have experience testing clinical trials database applications (including Oracle Clinical, ClinTrace / ClinTrial and ARGUS) and pharmaceutical development and process lab equipment (including chromatography) to 21 CFR part 11, and “GxP” standards (i.e. cGCP, cGLP, etc.) Working with SOPs and Validation documentation is the focus of my work experience.


Experience:
Over ten years of testing, QA, V&V and CSV experience.
Extensive understanding of QA as it applies to all phases of the development life cycle, including design verification, validation and acceptance testing. I am experienced developing strategic test plans, test cases/protocols and scripts and assuring that the system requirements are properly specified and have been satisfied, interfacing with various departments and vendors as required. I have performed testing products using black box, end-to-end and ad-hoc techniques. Knowledgeable and skilled in software QA testing: regression testing (both system and bug), acceptance testing, compatibility testing, system testing, functional testing, verification and validation, GUI and Internet testing. I enjoy working with biotech and medical projects, having successfully tested and qualified class 1 & 2 devices, complying with FDA (CFR) and ISO regulations. I have experience testing clinical trials database applications (including Oracle Clinical, ClinTrace / ClinTrial and ARGUS) and pharmaceutical development and process lab equipment (including chromatography) to 21 CFR part 11, and “GxP” standards (i.e. cGCP, cGLP, etc.) Working with SOPs and Validation documentation is the focus of my work experience.


Education:
BSCS Almeda College and AS degree IVY Tech State College. I have also completed various seminars, in-house training, self-study programs, as well college study. Studies including network theory, as well as programming in Lab View, Lab Windows, Basic, Visual Basic, VBA, as well as C/C++.


Affiliations:
American Society for Quality


Skills:
•Computer System Validation, Verification and Testing
•IQ/OQ/PQ and User Acceptance
•Validation Planning, Requirements, Standards, RBA (Risk Based Assessments)
•Test plan/suite development (QTP-Validation Plan)
•Test scripts/ verification and validation Plans and Protocols
•Clinical Database and Laboratory Systems and equipment validation
•cGxP (GCP-GLP) / 21 CFR part 11 e-records and signatures
•Sarbanes-Oxley (SOX)


Additional Information:
http://www.geocities.com/craig_patten/


Reference:
Available upon request.


Candidate Contact Information:
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