Job Description: SummaryThe Sr. IT Business Analyst - Quality works in close partnership with the Business Process Leader, BRM and other team members to understand Business Requirements and works with Software Vendors and Third Party Providers for the Analysis, Design, Implementation and Support of Technical Solutions for Quality and Regulatory Functions.
Solution Owner for Quality and Regulatory related platforms, both SAP and Non-SAP.
Subject Matter Expert within the Quality function.
Oversee the health of Quality Applications during the complete Application Lifecycle.
Work with Software Vendors and Third Party Providers for execution demand through delivery as outlined in the IT Operating Model:
Plan: Provides input to SDLC deliverables as defined in the Validation Plan, Compliance Plan or the Deliverables List.
Design: Provides input to Requirements Specifications, Risk Assessments, System Design Specifications and Design Reviews
Build: Provides input to OQ and PQ Test Scripts and the Traceability Matrix
Deploy: Ensures all the documentation for the project has been completed
Support: Review incident resolution activities and root cause analyses
Work with the BRM and the Domain Architect to determine a Solution Direction for Projects and Changes.
Review User Requirements to assure that they are crisp, clear and complete
Actively collaborate with Software Vendors and Third Party Providers to:
Translate User Requirements into System Requirements
Participate in the creation of the Project Plan
Review Effort Assessments
Participate in Project Status Meetings
Participate in Design Reviews to assure that requirements are met.
Assess System Risks and help develop mitigation plans.
Review Development Design
Monitor Development Progress.
Review Test Plans and Test Execution
Approve SDLC deliverables as defined in the Validation Plan
Participate in cutover preparation and execution activities
Participate in Hyper care activities
Assure that Support activities are prepared and monitor performance
Support system maintenance or upgrade activities as required.
Bachelor's Degree required.
Functional knowledge of Quality Systems (e.g. Inspection, Complaints, CAPA, MDR).
Has 4+ years of experience in an IT position in support of Quality Systems (e.g. SAP, Trackwise, and LIMS).
Familiar with working in a highly governed IT environment, subject to regulatory requirements.
Has a deep understanding in technology solution components
Familiar with structured portfolio & project management methodologies.
Strong Learning agility & self-development.
Interpersonal and cross-cultural skills
Proven skills in process management, time management, customer focus and problem solving.
Takes initiatives, shows creativity and innovation.
Strong Team Player
Primary Work LocationUSA NJ - Franklin Lakes
BD (Becton, Dickinson And Company)