PHARMACEUTICAL/BIO-TECH/LIFE SCIENCE EXPERIENCE PREFERRED
IT GXP (Validation Process) EXPERIENCE PREFERRED
Local on-site Senior Business Analyst with IT GxP process and Business Process implementation experience. The individual we are looking is a seasoned Senior Business Analyst with strong core skills, including communication, leadership, taking the initiative, and driving for results with little support from other BA team members. This person will need to be able to work in a very fast-paced and dynamic environment, yet, bring organization and control to the track(s) of BA work they manage.
? Implement advanced strategies for gathering, reviewing and analyzing requirements
? Prioritize requirements and create conceptual prototypes and mock-ups
? Master strategic business process modeling, trace ability and quality management techniques
? Apply best practices for effective communication and problem-solving
? Creates clear and concise documentation
? 7+ years analyst experience preferred.
? Ability to elicit business requirements and translate into technical solution design documents
? Working knowledge of business processes, system development and process improvements.
? Proficient in gathering business requirements using UML, process flows and uses cases.
? Expertise in modeling and mapping as-is and to-be business processes.
? Experience with complete software development life cycle.
? Understanding of technology capabilities and limitations.
? Experience with and strong understanding of various technologies and platforms, including end-point devices (i.e. mobile devices, laptops, tablets, servers, etc.)
? Experience designing and reviewing test cases.
? Experience with QA (GxP) process methodology
? Knowledge of SharePoint or similar collaboration portal
? Self-starter with strong problem solving skills
? Excellent verbal and written communication skills.
? Partner with cross-functional stakeholders (i.e.: IT Security team, Project Sponsor, Validation/Qualification team and Business counterparts, etc.) to elicit, analyze, and translate information to create Business Requirement , User Requirements, and/or Technical Requirements
? Act as a liaison between technical teams, senior management, and the business community, including managing communications between business stakeholders and technical teams
? Traceability Matrix creation and management
? Lead effort to obtain approvals for all types of Requirements
? Manage user change requests and change process
? Work with IT Security team, Project Sponsor, Validation/Qualification team and Business counterparts, etc. to gather and analyze information to develop new and update existing Process Flows and accompanying documentation (including swim-lanes diagrams and As-is & To-be documentation, etc.)
? Design comprehensive test plans to test the quality of software and business processes
? Work with IT Security team, Business counterparts, etc. to gather information to create User Acceptance Test Strategy documents
? Coordinate and manage user acceptance testing by providing test schedules, planning, test data, detailed test scripts and document test results
? Lead effort to obtain approvals for UAT Testing Summary, including the creation of the summary itself.
? Work with Technical and Training Team to help Trainers develop Training Plan, Materials and Training execution.
? Manage Training Plan approvals.