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*Job:* Software Developer *Interview:* Face to face *Duration: * 12-18 months *Location: * Wayne, PA** *Responsibilities:* 1. Manage the maintenance and implementation of system upgrades and enhancements to the *MasterControl EDMS system* and provide end user support. Troubleshoot and assist in resolution of operational issues for software applications 2.Gather requirements, create design specifications, and develop application enhancements, data interfaces and reports. 3.Identify and lead continuous improvement projects partnering with business stakeholders to define project scope, business requirements, project approach, budget, and schedule. 4. Participate in the design and development of test plans for executing unit, integration, system and validation testing ensuring FDA and other regulatory compliance 5.Develop and execute software validation protocols for version upgrades 6.Provide guidance in the areas of industry best practices as well as systems and solutions to improve effectiveness and efficiency. 7.Ensures all applicable electronic systems, including hardware, software, networks, etc. meet all FDA other regulatory requirements. *Required Skills:* 1. Bachelor’s Degree (B.A.) from a four-year college or university ; preferably with an area of concentration in Computer Science or Engineering with a minimum of 5 years related experience and/or training 2.5+ years of experience in systems analysis and software development with in depth understanding of the system development life cycle 3.5+ years design and coding with software development tools such as : *C#, Java, JavaScript, .Net, SQL Server, HTMA/DHTM/XML* 4.Experience with *electronic document management systems in FDA* regulated medical device or pharmaceutical company, experience, MasterControl preferred. 5.Hands on development experience with *SQL Server 2008, stored procedures, triggers* 6.Knowledge of processes in one or more areas of manufacturing, quality regulatory 7.Knowledge of and experience with *cGXP Software Validation, applicable FDA regulations and ICH guidelines*. 8.Working knowledge of ERP applications highly desirable 9.Strong skills in the areas of team facilitation, process mapping, solutions requirements gathering and problem solving -- You received this message because you are subscribed to the Google Groups "SRAOSS REKS" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/sraoss-reks. For more options, visit https://groups.google.com/groups/opt_out.
