BA for Manufacturing Area-- Memphis, TN
Remote On-Boarding OK (Yes/NO
Talent is expected to be at Memphis Area.
Must Have Skills:
7 to 9 of Total experience in IT industry and related field.
6 to 8 years of Business Analyst Experience in Life Science Domain in Manufacturing area.
Experience in Gather/understand the business requirements, analyze the requirements, carry out Fit Gap analysis and prepare the Business requirement document or User Stories.
Experience and good understanding on Good Manufacturing Practices, 21 CFR Part 11 and related regulatory requirements.
Nice to Have Skills:
Domain experience in Life Science, Pharma / Medical Devices.
Exposure on Validation requirements
Stakeholder Management and Project Management Skills
Detailed Job Description:
Excellent Communication Skills
Good Documentation Skills
Real time experience in requirement gathering, gap analysis and converting them into user stories.
Understand the regulatory requirements in Manufacturing area.
Liaise between Business User group and Technical / Solution Team.
Ability to develop and deliver
1 – Stakeholder Analysis.
2 – Business Analysis Plan.
3 – Current State Analysis.
4 – Scope Statement Specification.
5 – Functional Requirements Specification.
6 – Wireframes and Other Visual Documentation.
7 – Information or Data Model Documentation.
8 – Test Plans, Test Cases, or User Acceptance Test Plans.
Responsible to liaise with shop floor supervisors to understand their end to end Business process that includes tracking device history records for the materials that are produced, product handling procedures, shop floor digitalization, recoding the measurements, capture validation and Audit requirements. Help them with a solution to digitize their data entry that are handled today in a paper based forms.