Job
Description
The Computer Systems Quality Assurance Representative role is responsible for ensuring the Functional Area(s), Project(s) or System(s) to which they are assigned are in compliance with corporate Computer System Validation (CSV) standards. This includes providing consulting and interpretation of Corporate Computer Systems Standards and Practices, providing oversight for CSV execution (including approving CSV documents per corporate standards/practices), maintaining awareness of corporate and external standards as they relate to CSV, and assurance of inspection readiness within supported areas. This CSQA Representative position will be located at LCCI. Key Objectives/Deliverables: Maintain Inspectional Readiness Ensure supported systems are validated in compliance with applicable policies and procedures Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood Ensure all Inspection Readiness materials are current and appropriate Provide periodic updates to key stakeholders Escalate issues appropriately Deliver Projects, Programs, and Support Provide consulting and interpretation on standards and procedures as related to the supported computer system Provide training to customer areas on CSV-related topics as needed Partner with Business, Business Quality, and IT customer areas to deliver business value Understand customer, company, and Quality priorities Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed Engage customers and QA management in appropriate discussions of risk management Ensure suppliers of computer systems or services meet quality expectations Escalate computer system quality issues to the appropriate persons Strive for and promote consistency within the CSQA Organization IT QMS Support: Drive compliance culture through common process /services Through key relationships with quality and TechLilly, ensures an overall ongoing state of IT compliance is achieved and maintained related to common processes Advise on LCS Common quality management system, especially in relation to the processes owned by their role. Other processes include: CAPA management Deviation Management Periodic reviews Personnel Qualification Problem Management System Retirement Provide periodic updates to key consumers of service Provide oversight, direction, and continuous improvement to the LCS common processes owned by their role Streamline and Continuously Improve Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality. This may include engagement in Six Sigma projects and other process improvement activities. Identify opportunity for streamlining and simplification and assist in developing improved solutions Understand external trends and potential ramifications for the supported IT area(s) Grow Capabilities and Knowledge Share lessons learned and best practices with others Act as an engaged team member Basic Requirements: Bachelor (4 yr. College) degree in a technology-related field such as Computer Science. 3+ years experience in Automation/IT or computer system validation Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborate Proficiency with IT systems development life cycle Proficiency with corporate Computer Systems Validation practices and demonstrated ability to right-size validation based upon risk Ability to focus across multiple processes (end-to-end viewpoint) Additional Skills/Preferences: Understanding of process development and/or improvement (e.g. Six Sigma) Knowledge of multiple business areas Broad IT technical competency Ability to relate system use to potential impact to products and patients Knowledge of IT Best Practices (e.g., LSEF, ITIL) Practical application of IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))
