Senior Specialist, Qa It Systems

Job Description
Purpose
The Sr Specialist QA IT Systems is responsible for providing support of the development/configuration of Quality Lab software associated with the delivery of Lab-of-the-Future. In addition to supporting software development/configuration from business perspective this role will be instrumental in managing validation workflow for technology solutions provided including:
reviewing software requirement documents;
writing and reviewing validation documents;
executing and reviewingvalidation test cases;
and updating departmental procedures. This position ensures that defined software validation practices and procedures are being followed and that business requirements are being met.
Responsibilities
Work within project teams to ensure business requirements are understood and translated into applicable requirements documents as part of the SDLC process.
Ensure software quality assurance is achieved while meeting project objectives and deliverables;
review validation deliverables to ensure consistency with defined practices and procedures.
May participate as a team lead or team member on Lab-of-the-Future digital workstream projects.
Manage one or more of the required validation activities such as requirement document/ protocol authoring, review of validation documents, storage of controlled documents and resolution to incident/exception reports.
Responsible for implementing Quality Control standards into departmental documents and ensuring all departmental training is complete.
Provide direction to business and IT stakeholders and project team members regarding software validation/QA issues.
Act as a liaison between IT department and other Quality Control/Assurance departments.
Interface directly with FDA and other regulatory agencies during audits.
Must complete project tasks within time and budget constraints.