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Job title

QA Test Engineer and QA Compliance Management Positions

Company Image Solutions
Wage between $0.00 - $0.00 Hourly
Location United States, New Jersey, Whippany
Employment type Full Time
Education Bachelor
Year Experience 3 - 4 Years of Practical Experience
Travel None
Published on 1/18/2007
Description


About Image Solutions, Inc.

Founded in 1992 by president and CEO, Jinsoo Kim , Image Solutions, Inc. (ISI) has played a pioneering role in the worldwide movement toward acceptance and standardization of PDF-based electronic submissions.  Today, ISI is a recognized leader in the area of electronic submissions of New Drug Applications (NDA's).  By designing, developing, implementing, and supporting advanced imaging technologies, ISI has assisted many of the world's foremost pharmaceutical companies in reducing the time and cost associated with eNDA development, compilation, submission, and review.  Furthermore, ISI has applied our expertise to expand our offer to Legal, Insurance, Financial Services, Publishing, and other regulated industries.  With our staff of highly trained professionals, ISI offers a wide array of innovative and specialized products and services.  ISI and our associates have a broad range of expertise in workflow design, project management, document management, medical writing, software design, development and training, as well as systems and software integration.  We are uniquely positioned to help our customers with our ability to provide the appropriate mix of software technology, professional services, and/or training to ensure our client's success.

 

ISI's innovative work is included in the Smithsonian Institution's "Innovation in Science Collection" as a pioneer in the movement toward acceptance and standardization of Electronic Submissions to the FDA.  Additionally, Integrity, Satisfaction, and Innovation have propelled ISI to Deloitte & Touche's prestigious "Technology Fast 50 " program in New Jersey and "Technology Fast 500" program in the U.S. four years in a row.

Visit our Website at www.imagesolutions.com.

We Provide:

  • Comprehensive Medical Coverage
  • Comprehensive Dental Coverage
  • Prescription Drug Coverage
  • Vision Discount Program
  • Pre-Tax Benefit Contributions
  • Life Insurance
  • Accidental Death and Dismemberment
  • 401K Retirement Plan
  • Paid Time Off (PTO) Program
  • Employer Matching Gift Program
  • Business Casual Dress Code
  • Employee Activities
  • Plus Much More...

"The Fine Print:"

  • You must specify previous salary earned and minimum salary expectations when applying
  • No third party resumes will be considered
  • No phone calls please
  • ISI is an Equal Opportunity Employer

 

Join our growing Company as a:
QA Test Engineer

The QA Test Engineer is the ISI expert on the software testing process and ISI software applications.  The incumbent is responsible for testing various ISI applications in accordance with internal processes and procedures along with meeting the needs of our client's regulatory requirements.  Aside from the testing, the engineer creates and reviews test plans, test scripts, summary reports and other relevant validation documentation along with user acceptance testing.

In this position you will:

  • Become familiar with the ISI software development process, and sustaining proper validation procedures to ensure compliance with industry-accepted standards (e.g., GAMP, FDA regulations, ISO).
  • Develop and update test plans, test cases, test environment, and all other relevant validation documentation through the software life cycle to ensure completeness and accuracy.
  • Perform various levels of testing of ISI software (performance, system, regression, ad-hoc, user acceptance, etc.).
  • Identify, assess and report issues and verify bug fixes. (Variance / Regression Tests).
  • Closely work with software developers, product support and business analysts.
  • Performs all duties in accordance with company and departmental standards.
  • Develop an in-depth knowledge of Computer Systems Validation and 21 CFR Part 11 guidelines

Please visit our website to view other QA positions! www.imagesolutions.com

Experience/Skills
  • Bachelor's degree from four-year college or university and 2 to 5 years related experience; or advanced degree and 2 to 5 years related experience; or equivalent combination of education and experience.
  • Ability to work with specific computer software such as Microsoft Office Products, including but not limited to: Word; Excel; PowerPoint; Outlook; Internet Explorer.  Knowledge of relational database (RDBMS) preferably Oracle, IIS, automated testing tools a plus.
  • Awareness of pharmaceutical and technology industry trends.
  • Knowledge of development practices and standards
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