Quality Control Specialist

About the role

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

Responsibilities

• 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)

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.
• 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