Data Integrity Validation Analyst
Location: Durham, NC
Job Category: Other Area(s)
PRINCIPAL DUTIES & RESPONSIBILITIES: As a member of the IT Quality & Regulatory Compliance team, the ITQ - Data Integrity Analyst helps to define, plan, and perform duties that support major system development life cycle activities, data integrity
JOB DEMANDS: This job requires the Quality Assurance and Data Integrity Specialist to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The Quality Assurance and Data Integrity Specialist must maintain a professional manner in representing the company and in working with its agents and associates. The Quality Assurance and Data Integrity Specialist 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.
1. Assist management in the development and execution of plans required to address corporate data integrity system gaps for GxP applications.
2. Lead in the development/evaluation/update of IT Controls, i.e. procedures, work instructions, templates and other tools to ensure needed changes/updates for Data Integrity are included.
3. Identify and complete Data Integrity-related deliverables and activities in regard to corporate SOPs and current regulations for GxP applications such as:
• Verify that data integrity related data is captured in Audit Trails. Identify the types of audit trails that need to be captured and how often to review.
• Identify system integrations from the primary system of record and critical data flows between them.
• Perform Data Mapping for critical data, metadata and data flow through the data life cycle for stand-alone and integrated systems.
4. Assists in the development of training materials and provides guidance, training, and support to IT personnel in their Data Integrity efforts, to ensure compliance.
5. Advises technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed, from a Data Integrity standpoint.
Bachelor’s Degree in Computer Science, Management Information Systems or equivalent. • 10 or more years of experience in Computer Systems Validation environment with at least 2 years performing in the IT Quality and Compliance and/or data integrity roles.
• Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) and Data Integrity (including MHRA, FDA regulations and guidelines).
• Strong understanding and experience interpreting data integrity regulatory requirements and data governance principles. Evidence of using this knowledge to create training materials /perform effective training of individuals on data integrity/data governance principles and the performance of CSV to ensure data integrity.
• Experience evaluating, designing/redesigning business rules, processes, definitions, quality expectations and checks & balances to ensure data integrity in a scalable and efficient manner.
• Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL.
• Excellent communication skills, both verbal and written.
• Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment.
• Knowledge of general software and database concepts.
• Experience with risk analysis, risk management and computer system periodic review practices and tools.
• Knowledge of infrastructure technology and platforms.
• The ability to management projects, work independently and with teams at various levels in the organization in waterfall and agile environments.
• Excellent organizational and problem solving skills and attention to detail and accuracy.