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Process Software Analyst
* Develops and executes validation protocols / verifications for software processes using FDA guidelines and establishes technical files and reports.
* Develops test strategies and creates data to apply test scripts based on requirements received from process owners and process development changes that will provide efficient coverage of requirements consistent with acceptable level of risk.
* Provides a user perspective during the development phase of new/modified code.
* Analyzes existing software processes and determines where improvements can be made to become more efficient and/or improve the quality of the process performed.
* Assists, where applicable, in the training of process changes as a result of software validations / verifications
* Assumes additional responsibilities/duties as requested by immediate supervisor, other management personnel or as business need dictates.
* Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
* Requires possession of an Associate’s Degree in Computer Science, Business Administration or Management related field or 1 – 5 years’ experience working in the software development / testing industry.
* Possession of Certifications and/or training in the QSR, ISO laws/guidelines, Six Sigma, Lean methodologies, or other continuous improvement tools/practices are a plus.
* Must demonstrate functional ability to use Microsoft Office Suite.
* Must have an ability to learn company software programs such as the ERP System.
* Must possess a broad knowledge of software development, as well as a strong understanding of business processes.
* Must have strong experience in understanding testing methodologies.
* Possess sound judgment, strong problem-solving ability and an ability to negotiate.
* Capable of collecting, analyzing, and summarizing information and trends.
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