Data Integrity Specialist I/GxP Data Integrity
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About The Position
The Data Integrity Specialist I position focuses on providing compliance support for GxP IT business systems within a research and development bio-pharmaceutical scientific organization. This role is critical in ensuring that all systems and user needs are thoroughly reviewed, analyzed, and evaluated to meet the compliance standards required in the biopharma industry. The specialist will document requirements and support the scope and objectives that align with the business strategies of the organization. In this role, the specialist will manage laboratory instrument systems and will work under the supervision of a team lead, which means that independent judgment is not typically required. Daily responsibilities include providing support to laboratory scientific staff, troubleshooting issues, enhancing systems, and conducting training sessions. The position emphasizes a highly collaborative, team-based environment where decision-making and project focus are achieved through a unified compliance approach. The specialist will also be responsible for identifying and recommending practical solutions to improve business process efficiency. This includes managing multiple tasks simultaneously while ensuring that all timelines are met. The ability to anticipate and respond to urgent or unexpected events with minimal impact on productivity is essential. Additionally, the role involves supporting compliance, business, and quality assurance partnership needs and initiatives aimed at continuous improvement to enhance efficiency and compliance. The specialist will provide input on regulatory and compliance requirements and will be expected to identify and escalate potential compliance risks or issues as they arise, using sound judgment to assess the criticality of these issues.
