Job Description :
Client: Direct
Salary: Negotiable
Business Analyst
Location: Saint Louis, MO
Full Time
new position 08/28 - rk_ba_at_mo
Responsibilities:
· Performing, reviewing and/or approving quality and compliance work activities and documentation related to IT change management, computer system validation, periodic activities and software development.
· Assist in integrating the IT department with both site manufacturing quality and global IT quality processes procedures as well as assist in continuous improvement projects for IT quality and compliance operations.
· Manage projects and compliance activities as assigned.
· Perform BT Quality Management activities related to qualification, GXP validation, and change-management of IT systems.
· Provide technical expertise to write computer system lifecycle, validation, and decommissioning documentation in accordance with cGxP, 21 CFR Part 11, 210, and 211, and other applicable regulations and procedures.
· Develop and manage project documentation for SDLC requirements during computer system implementation projects including developing user and functional requirements; technical and functional business process flows, use case, test case and test script documents; perform functionality, usability and testing during required project phases.
· Perform IT system periodic activities and oversee the process for completion according to quality procedures.
· Assist in performing impact assessments and work with technical SMEs to close-out IT related CAPAs and commitment tracking items.
· Represent company BT in site level change control meetings and act as main point of contact for company BT core solution teams regarding change management, quality assurance and compliance management.
· Work with Site Quality Organization and company BT Quality Assurance personnel staff to review, update and approve all documentation.
· Act in a project lead and/or business analyst capacity for assigned projects to include performing project documentation, tracking and communicating project status and status of deliverables, risk and issue analysis and problem resolution.