Curium Pharma · 1 week ago
(Contractor) Data Integrity Specialist
United States
Full-time, Contract
Onsite
Mid Level
3+ years expCurium Pharma is the world’s largest nuclear medicine company, focusing on the development and distribution of radiopharmaceutical products. The Data Integrity Specialist will support electronic and paper-based systems at the Maryland Heights facility, ensuring data integrity compliance and conducting assessments.
Pharmaceutical
Responsibilities
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
Qualification
Required
Bachelor Degree preferred or equivalent work experience
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.)
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
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
Company
Curium Pharma
Curium is a world-class nuclear medicine solutions provider with over 100 years of industry experience.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2017-04-06Acquired
Leadership Team
Benoit Woessmer
CEO PET Europe
Michael Patterson
Chief Executive Officer - North America
Recent News
Curium US LLC
2025-12-03
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