IVD Assay Validation Consultant | Characterization & QA

Creative Solutions Services, LLC

Indianapolis (IN)

Hybrid

USD 83,000 - 165,000

Part time

11 days ago

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Benefits offered by this job

Flexible consulting/contract

Competitive hourly or project-based

Long-term collaboration potential

Job summary

Creative Solutions Services, LLC seeks an IVD Assay Characterization & Validation Consultant to drive CLSI-aligned validation protocols and regulatory documentation for automated clinical chemistry assays in Indianapolis, IN. This hands-on role requires translating complex assays into scalable diagnostic products.

The candidate will lead multi-day evaluations on automated platforms (Cobas preferred), design matrix studies, mentor staff, and assemble FDA Q-Sub packages, while working a hybrid 3

Qualifications

BS/MS/PhD in a relevant scientific field with clinical chemistry focus.
2 years of regulated IVD development, validation, or characterization.
Experience with CLSI guidelines and regulatory documentation.

Responsibilities

Design CLSI-compliant validation protocols and analytical verification.
Lead on-site operations for automated clinical chemistry platforms (Cobas).
Conduct multi-day evaluations, spike-and-recovery, and matrix studies.
Draft Method Validation Reports and regulatory packages for FDA Q-Sub.

Skills

CLSI Protocols

Analytical Troubleshooting

Cross-Functional Communication

Education

Bachelor's in Chemistry/Biochemistry/Clinical Chemistry

MS or PhD in related field

Tools

Cobas analyzers

Validation software

Job description

The candidate will lead multi-day evaluations on automated platforms (Cobas preferred), design matrix studies, mentor staff, and assemble FDA Q-Sub packages, while working a hybrid 3

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