Job Title : Test Analyst Location : Swiftwater, PA Contract : 4 months The contractor will participate in Validation processes and activities supporting key system enhancement projects and master data management updates for the LabWare LIMS in the IS Department in North America, and to provide dedicated support for the IS Support Team. Duties: - 5 years experience with validation of IS computer systems in an FDA regulated environment - Understanding of GxP regulations and Computer Validation principals - Understanding of Document Management principals - Demonstrated technical writing and oral communication skills - Strong interpersonal skills Experience in system administration or "super user" role with LabWare LIMS v5 or later - Overall proficiency/familiarity with all key features of LabWare LIMS - Proficiency/experience with implementing master data modifications in LabWare LIMS -- analyses, product specs, sample plans etc. - Proficiency/experience with LWLIMS stability features -- application and master data (e. g., stability protocols, stability studies, etc.) - Ability to quickly learn how North America uses LWLIMS (e. g., how master data is used to implement business processes, how the application is customized, etc.) Validation - Proficiency/experience in a regulated (e. g., GxP) environment - Proficiency/experience with HP Quality Center (testing tool) and TrackWise (change management tool) - Proficiency/experience with writing clear, concise, complete test scripts, with appropriate test coverage, for a given master data or application change - Proficiency/experience in completing unit tests of master data modifications or similar in LabWare LIMS - Proficiency/experience with executing integration tests of application modifications, using provided test scripts Other skills - Balance of technical capability, process understanding, interpersonal skills, and pharmaceutical/business familiarity - Detail oriented -- ability to get things done "right the first time" in a regulated environment - Ability to work independently and efficiently and deliver quality results within the established time frames (thus maximizing output with sufficient quality, while also minimizing the need for unnecessary involvement from teammates or business contacts) - Ability to work collaboratively, so that pertinent issues are addressed as efficiently as possible - Ability to juggle multiple priorities simultaneously (in order to keep multiple project assignments moving forward, even as priorities are changing) - Ability to quickly learn the steps in the IS change management process - Ability to work within the existing IS processes and procedures, using existing document templates, naming conventions, checklists, etc. Education Bachelor degree: Computer Science (preferred) or Business/Sciences with computer science concentration Prospective Candidates mail your resumes to firstname.lastname@example.org or call me at 630-324-0006 Extn 109
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