Data Integrity Specialist

Essential Functions

• Review system documentation (e.g., user manuals, SOPs, validation reports)
• Conduct system assessments and inspections.
• Analyze audit trails for evidence of data manipulation, deletions, or unauthorized access.
• Review data for completeness, accuracy, and consistency.
• Assess data backup and recovery procedures.
• Evaluate user access controls and permissions.
• Compare current practices with data integrity requirements.
• Identify and remediate gaps and deficiencies.
• Prioritize identified gaps based on risk.
• The contract staff will document the assessment process, including findings, recommendations. 
• Maintain current knowledge of federal and international data integrity regulations
• Manage and prioritize project in an organized and structured manner
• Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EP, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
• Complete Periodic Reviews of equipment.
• All other responsibilities as assigned with or without accommodation.

Requirements

• Bachelor Degree preferred. Work experience is considered in lieu of degree.
• Three or more years of relevant work experience understanding and interpreting cGMP, GLP or GCP regulations with a focus on Data Integrity requirements
• Candidates must understand how to apply regulations within manufacturing and laboratory environments.
• Experience reviewing / authoring standard operation procedures.
• Proficiency with core computer software / systems (Microsoft Word, Excel, SharePoint, Project, etc.) 

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.  
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8 hours a day while performing duties.  
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants. 
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.