Data Integrity Specialist

The Data Integrity Specialist will support electronic and paper-based systems.

Essential Functions

• Research Laboratory and Manufacturing processes to develop compliance gap assessments related to data integrity.
• Understand Laboratory and Manufacturing data life cycles to develop data maps.
• Report on progress of data integrity work and significance of the results.
• Complete Periodic System Reviews according to schedule, working with system administrators and subject matter experts to accurately assess the systems and the associated data.
• Assess risks related to data integrity and collaborate with colleagues to mitigate and implement appropriate corrective actions.
• Assist Laboratory and Manufacturing personnel with development of procedures, job aids and other documentation to improve the overall site compliance stance.
• Perform data integrity training using approved course curriculum
• Utilize expertise and information on data integrity to assist Laboratory and Manufacturing personnel on compliance issues.
• Maintain current knowledge of federal and international data integrity regulations.
• Work independently and manage workload.
• Manage and prioritize project in an organized and structured manner.
• Maintain the required percentage complete on all assigned site training.
• Perform all work in compliance with site safety and radiation protection guidelines.
• Author standard operating procedures.
• Create data maps for laboratory and manufacturing systems.
• Assist site staff in adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• All other responsibilities as assigned with or without accommodation.

• Bachelor Degree preferred. Work experience is considered in lieu of degree.
• Three or more years of relevant work experience required.
• Candidates must understand how to apply regulations within manufacturing and laboratory environments.
• Experience reviewing / authoring standard operation procedures.