Quality Control Specialist

Eurofins Clinical Diagnostics; Centennial (WY); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

Comprehensive medical coverage

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins Clinical Diagnostics in Centennial, Wyoming is seeking a quality control professional. Candidates must support quality standards, perform routine reviews, and maintain regulatory compliance. A Bachelor's degree in a relevant field and 2–4 years of experience in clinical laboratory quality control are required.

The role offers a salary range of $65,000 to $75,000 annually, along with excellent full-time benefits, including medical coverage, dental, vision options, and a 401(k) with company match.

Qualifications

• 2–4 years of experience in clinical laboratory quality control.
• 1-2 years of experience with assay and equipment validations.
• Ability to adhere to biosafety protocols.

Responsibilities

• Support Eurofins DPT’s quality and safety standards.
• Perform routine quality control reviews of diagnostic assays.
• Analyze QC trends and participate in root cause investigations.

Skills

Data analytics using relevant statistics

Strong communication skills

Proficiency with laboratory instruments

Education

Bachelor’s degree in chemical, biological, or clinical laboratory science

Tools

LIMS and electronic analysis systems

Job description

Job Description

• Support Eurofins DPT’s quality and safety standards, leadership values, and compliance with regulatory and accreditation requirements (e.g., CLIA, CAP, FDA).
• Understand the application of regulatory standards and guidance documents and work with RA/QA personnel to ensure standards are met and update department management on updates to validation policies and procedures.
• Perform routine and non-routine quality control review of diagnostic assays, equipment, laboratory SOPs, and manufacturer specifications.
• Analyze QC trends, identify deviations, and escalates issues as needed. Participate in root cause investigations and implement corrective/preventive actions (CAPAs).
• Maintain accurate and complete records in accordance with regulatory guidelines (e.g., CLIA, FDA 21 CFR Part 11, ISO 15189).
• Participate in quality audits or regulatory inspections.
• Assist with the validation and verification of new instruments and diagnostic assays, including performance specifications (accuracy, precision, sensitivity, specificity, etc.).
• Participate in test performance verification and assist in validation of new methods or instruments as needed.
• Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
• Support training efforts for laboratory personnel. Assist in the creation, review, and revision of SOPs and QC-related documents.
• Identify, document, and escalates QC deviations or trends; assist in investigations and CAPA processes.
• Work closely with Laboratory Operations and Department Managers to ensure integration with ongoing testing and method implementation.
• Maintain clear, accurate, and timely documentation of all activities, results, deviations, and corrective actions.
• Demonstrate proficiency with LIMS and electronic analysis and tracking systems.
• Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and internal quality systems.
• Perform assigned tasks according to prescribed procedures and make accurate observations and records of tests results.
• Ability to safely work within an environment in which potentially infectious human blood and body fluids are present, utilizing all appropriate personal protective equipment (PPE).
• Follow all Good Laboratory Practices and Good Documentation Practices.

Minimum Requirements

• Bachelor’s degree in chemical, biological, or clinical laboratory science, or medical technology from an accredited institution.
• If applicable, current and valid State License to perform clinical laboratory testing.
• Ability to work in environments involving potentially infectious blood, serum, or other clinical materials, with strict adherence to PPE and biosafety protocols.

Work Experience Requirements

• Experience in a high‑complexity testing environment; document 2–4 years of experience in clinical laboratory quality control or regulated laboratory testing environment.
• 1-2 years of experience with assay and equipment validations.
• Basic project management.
• Knowledge of technical writing and study design.
• Working knowledge of CLIA, CAP, FDA (21 CFR Part 11), and/or ISO 15189 standards.
• Capability to perform data analytics using relevant statistics and/or mathematics.
• Strong communication skills and analytical thinking.
• Experience interpreting quality control data and performing root cause analysis.
• Proficiency with laboratory instruments, quality control procedures, and statistical data analysis.
• Effective communication skills and the ability to collaborate across functional teams.
• Experience with control systems, deviation handling, and CAPA processes.
• Experience participating in quality audits or inspections.
• Knowledge of regulatory standards applicable to method validation testing and analysis.
• Ability to troubleshoot.

Potential Environmental Factors

• This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins DPT’s Safety and Exposure procedures, including the use of provided safety clothing and equipment.
• Work is performed in a clinical laboratory setting with possible exposure to infectious materials.
• All employees are required to follow Eurofins DPT Safety and Exposure Control Procedures, using appropriate PPE and safety equipment.
• Refer to SDS sheets for specific chemical hazard information.
• Some lifting of equipment or materials (up to 25 lb) may be required.

Compensation

• $65,000-$75,000/year

What We Offer

• Excellent full‑time benefits including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.

Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.