Primary Responsibilities Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by · Tracking all software versions, features, bugs and validation efforts for all software created and/or modified by the Development teams. · Developing and utilizing test data sets that support the implementation of test plans and procedures. · Creating and executing manual test scripts which includes testing software applications for quality and functionality using defined validation protocol and testing techniques. · Creating associated validation documentation using defined documentation methods. · Writing comprehensive test plans and reports which set strategy and summarize results. · Working with application developers in resolving issues and retesting applications. · Partnering with technical and business teams to achieve understanding of current and future functionality. · Accurately assessing the risks associated with each design solution / project. · Exceling at business negotiation, ability to interact with clients, team members, various levels of management and external groups. · Compiling and maintaining the documentation for an assigned project and working closely with Quality Assurance to obtain their sign-off and approval · Communicating status frequently and noting current issues to the Group Leader Maintains Quality Service and Departmental Standards by · Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) · Assisting in establishing and enforcing departmental standards including defining, documenting and implementing validation standards as needed Secondary Responsibilities Contributes to team effort by · Exploring new opportunities to add value to organization and departmental processes · Working with internal staff including technical staff, project and product managers and applications developers to assist with the review of project specifications · Helping others to accomplish results · Performing other duties as assigned and deemed necessary Maintains Technical and Industry Knowledge by · Attending and participating in applicable company-sponsored training

Education: · Bachelors degree in Computer Science, Engineering, Life Sciences or related field required (Extensive experience and training may be considered in lieu of Bachelors degree.) Experience: · 3+ years experience in validation/software testing required. · Must have experience working with computer software including Word, Excel and SQL · Knowledge of software development tools and Software development Life Cycle. · Proven ability in problem solving and troubleshooting. · Proven mentoring and/or supervisory skills required.