Quality Control Specialist

Quality Control Specialist

Support Eurofins DPT's quality and safety standards, leadership values, and compliance with regulatory and accreditation requirements (e.g., CLIA, CAP, FDA).

Understands the application of regulatory standards and guidance documents and works with RA/QA personnel to ensure standards are met and update department management to updates on 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 escalate 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).

Participates 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 escalate 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 to 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)

Follows all Good Laboratory Practices and Good Documentation Practices

Qualifications

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.
• Capable of 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.
• Control systems, deviation handling, and CAPA processes preferred.
• Experience participating in quality audits or inspections.
• Knowledge of regulatory standards that are 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. This includes using the 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 lbs) may be required.
• For a list of potential chemical hazards, see appropriate SDS sheet.

Additional Information

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.