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Senior IVD Assay Validation Specialist; Hybrid

Job in Indianapolis, Hamilton County, Indiana, 46262, USA
Listing for: Talentburst,-Inc
Full Time position
Listed on 2026-11-02
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 83000 - 165000 USD Yearly USD 83000.00 165000.00 YEAR
Job Description & How to Apply Below
Position: Senior IVD Assay Validation Specialist (Hybrid)
Location: Indianapolis

Roche Diagnostics in Indianapolis is seeking an IVD Assay Characterization & Validation Consultant to drive technical characterization, CLSI-compliant validation, and regulatory documentation for automated clinical chemistry assays. This role combines hands-on bench work with cross-functional collaboration across regulatory, QA, and manufacturing teams.

You will lead multi-method matrix studies, author technical packages for FDA Q-Sub submissions, and mentor staff while ensuring quality and

We are looking to fill the Senior IVD Assay Validation Specialist (Hybrid) position at Talentburst,-Inc in Indianapolis, IN, United States.

Join Talentburst,-Inc and contribute to our ongoing work.

Take a moment to read everything above and see whether this role is right for you.

This posting is for the Senior IVD Assay Validation Specialist (Hybrid) role at Talentburst,-Inc, based in Indianapolis, IN, United States.

The Senior IVD Assay Validation Specialist (Hybrid) role at Talentburst,-Inc is now open for applications in Indianapolis, IN, United States.

Position Requirements
10+ Years work experience
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