IT Quality Analyst
Location: Cambridge, Massachusetts
Job Category: Pharmaceuticals
IT Quality Analyst
This job requires the IT Quality Analyst to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The IT Quality Analyst must maintain a professional manner in representing the company and in working with its agents and associates. The individual should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.
• Approve system life cycle deliverables (SDLC} and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
• Represent IT Quality on cross-functional teams with IT R & D in support of SDLC activities.
• Consult on the authoring and conformance of validation-related deliverables and activities in regards to corporate
SOPs and current regulations.
• Provide guidance, training and support to IT personnel in their validation efforts, to ensure compliance.
• Provide quality assurance oversight for system related issues (Test incidents, issues, etc.)
• Advise technical personnel and project teams on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
• Bachelor's/Master's Degree
• 7+yrs IT QA/Validation exp in computerized system validation in a regulated environment
(preferably R&D application)
• Thorough knowledge of GxP and ERES (21CFR Part 11 and Annex 11) regulations and guidelines
• Detailed knowledge of the IT SDLC and software quality assurance in a regulated environment
• Thorough knowledge of IT Controls methodologies, including GAMPS and ITIL
• Experience with risk analysis and risk management practices and tools
• Excellent communication skills, both verbal and written
• Knowledge of general software, database concepts and Data Integrity
• Knowledge of infrastructure technology and platforms
• The ability to work both independently and with teams