(Contractor) Data Integrity Specialist

Curium Pharma

Noblesville (IN)

On-site

USD 70,000 - 90,000

Full time

3 days ago
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Job summary

Curium Pharma in Noblesville, IN seeks a Contractor Data Integrity Specialist to support electronic and equipment systems at the facility.

The role centers on assessing data integrity, reviewing system documentation, and ensuring compliance with FDA, EP, and international guidelines while maintaining audit-ready records. Core tasks include data review, access controls, and remediation of gaps.

Qualifications

  • Three or more years of relevant work experience understanding and interpreting cGMP, GLP or GCP regulations with a focus on Data Integrity requirements.
  • Experience reviewing / authoring standard operating procedures (SOPs) and regulatory documents.
  • Proficiency with core software (Word, Excel, SharePoint, Project) and documenting assessments.

Responsibilities

  • Review system documentation (e.g., user manuals, SOPs, validation reports).
  • Analyze audit trails for 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.
  • Identify and remediate data integrity gaps and deficiencies.
  • Document assessment findings, recommendations, and regulatory alignment.

Skills

Data Integrity
cGMP compliance
Regulatory understanding
Analytical thinking
Documentation review

Education

Bachelor’s degree preferred

Tools

Microsoft Word
Excel
SharePoint
Project

Job description

Contractor Data Integrity Specialist

Date: Sep 8, 2026


Location: Noblesville, IN, United States, 46060


About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.


Summary of Position

We are seeking a contractor who will provide Data Integrity support for electronic and equipment systems at the Noblesville, IN facility.


Work Schedule: Monday - Friday 8am - 4:30pm


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.


Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.


Equal Opportunity Employer

Curium is anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.


We believe diversity includes disability, and we actively encourage applications from people with disabilities. If you require any accommodations during the recruitment process, please let us know-we are happy to support you.


Job Segment:


  • Forklift

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  • Laboratory

  • Developer

  • Sharepoint

  • Manufacturing

  • Technology

  • Science

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