Data Integrity Specialist

Role: Data Integrity Specialist

Location: New York City Metropolitan Area On-site

Summary:

The specialist will provide guidance as a liaison between the Data Governance Team and other areas to identify and address issues related to Data Integrity and Data Governance.

The specialist will work with multiple functional areas to implement policies and procedures to ensure compliance with GxP industry regulations.

The specialist provides support and guidance of quality system records activities such as change controls, risk assessments, corrective and preventive action plans (CAPAs), standard operating procedure (SOPs), work instructions/job aids, policies, etc.

This role requires interactions with personnel at all levels across multiple functional areas to ensure timely completion of Quality Assurance responsibilities.

Job Responsibilities include, but are not limited to, the following:

• Ensures GxP quality standards, applicable regulatory compliance, and company guidelines/policies are created and maintained through the development of the Data Governance Program
• Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects
• Assist in creating and managing Data Governance Program metrics, policies, and projects
• Ensures new systems/processes/procedures are compliant with SOPs, WIs and data and regulatory guidelines.
• Assist in resolution of inspection management concerns as it relates to process, procedures, and data integrity
• Reviews deviations, change controls, SOPs and corrective actions to assess for compliance with established regulatory requirements, GxP guidance and company policies and procedures.
• Investigates compliance problems and recommends solutions to improve compliance and prevent repeat occurrences of deviations.

Experience:

• 7 years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA regulated manufacturing environment.
• Thorough understanding of IT CSV, IT QA, and Data Governance roles and responsibilities in support of GxP compliance is required
• Experience working in an FDA regulated environment with a strong emphasis on a risk-based approach to validation/qualification
• Strong knowledge of FDA CFRs, EudraLex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing)
• Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology and Software Quality requirements.
• Understanding of root cause analysis and risk management techniques
• Experience with quality management systems including change control, incident management, and deviation management.
• Strong Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation – e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc.
• Continuously drive to improve processes for improved performance
• Excellent technical writing and communication skills
• Excellent analytical and problem-solving skills