Quality Control Analyst – Clinical Diagnostics

RXinsider LTD.; Wyoming (OH); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins Scientific seeks a quality-focused professional to support regulatory compliance and QC activities in a high‑complexity testing lab. You will review assays, SOPs, and equipment, analyze data, and escalate issues with root cause investigations.

The role involves maintaining GLP/GDP practices, documenting deviations, and collaborating with Laboratory Operations to ensure method implementation. Experience with CLIA, CAP, FDA regulations is preferred.

Qualifications

• Bachelor’s degree in chemical, biological, or clinical laboratory science or medical technology.
• State license to perform clinical lab testing if applicable.
• Ability to work in environments with infectious materials with PPE adherence.

Responsibilities

• Support quality and safety standards and regulatory compliance (CLIA, CAP, FDA).
• Review diagnostic assays, equipment, SOPs and manufacturer specs.
• Analyze QC trends, identify deviations and escalate issues when needed.
• Maintain records per regulatory guidelines (CLIA, FDA 21 CFR Part 11, ISO 15189).
• Participate in quality audits or inspections and CAPA processes.
• Assist validation/verification of instruments and new methods.

Skills

High‑complexity testing

Quality control experience

Root cause analysis

Data analytics

Regulatory standards knowledge

Communication skills

Team collaboration

Troubleshooting

Education

Bachelor’s degree in chemical/biological/clinical lab science

Tools

LIMS

Job description

Eurofins Scientific seeks a quality-focused professional to support regulatory compliance and QC activities in a high‑complexity testing lab. You will review assays, SOPs, and equipment, analyze data, and escalate issues with root cause investigations.

The role involves maintaining GLP/GDP practices, documenting deviations, and collaborating with Laboratory Operations to ensure method implementation. Experience with CLIA, CAP, FDA regulations is preferred.