Assay Validation & Data Integrity Analyst

Research & Diagnostic Systems, Inc.; Minneapolis (MN); On-site; USD 56,000 - 91,000; Full time

Job summary

Bio-Techne is seeking a professional to perform assay value assignment and assist with product validation activities. You will organize, analyze, and evaluate data to assign assay values, compare values to release specs, and compile validation data for reports.

The role involves writing and maintaining procedures, collaborating with the Product Validation Manager on validation summaries, and ensuring proper documentation and record keeping.

Qualifications

• BS degree in Medical Technology or Biological Sciences or equivalent.
• 3–5 years of related experience in a lab or QA setting.
• Hematology experience preferred.

Responsibilities

• Perform assay value assignment.
• Prepare assay sheet data for templates.
• Maintain product history for value assignments.
• Coordinate with QA/Regulatory for validation summaries.
• Prepare COAs for OEM customers.
• Review and proofread proofs and records.
• Assist with calibration decisions for internal analyzers.

Skills

Data analysis

Communication

Problem solving

Attention to detail

Independent work

Education

BS in Medical Technology or Biological Sciences

Tools

Microsoft Word

Excel

Laboratory equipment

Job description

Bio-Techne is seeking a professional to perform assay value assignment and assist with product validation activities. You will organize, analyze, and evaluate data to assign assay values, compare values to release specs, and compile validation data for reports.

The role involves writing and maintaining procedures, collaborating with the Product Validation Manager on validation summaries, and ensuring proper documentation and record keeping.