Quality Control Specialist

About the role

Eurofins Scientific is an international life sciences company dedicated to ensuring the safety, authenticity, and quality of products across various industries. As a Quality Control Specialist, you will play a crucial role in supporting the company's quality and safety standards, regulatory compliance, and maintaining high-quality laboratory practices.

Responsibilities

• Support Eurofins DPT’s quality and safety standards, regulatory compliance, and adherence to CLIA, CAP, FDA, and other relevant standards.
• Understand and apply regulatory standards and guidance documents, working with RA/QA personnel to ensure compliance and updating department management on validation policies and procedures.
• Perform routine and non-routine quality control reviews of diagnostic assays, equipment, laboratory Standard Operating Procedures (SOPs), and manufacturer specifications.
• Analyze QC trends, identify deviations, and escalate issues as necessary. 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 validating new methods or instruments as needed.
• Develop and implement new and improved validation engineering techniques and procedures.
• Support training efforts for laboratory personnel. Assist in creating, reviewing, and revising 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 accurately record test results.
• Able to safely work in environments involving potentially infectious human blood and body fluids, adhering to all PPE and biosafety protocols.

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.
• Experience Requirements:
• Experience in a high-complexity testing environment, with at least 2-4 years of experience in clinical laboratory quality control or regulated laboratory testing environment.
• Experience with assay and equipment validations.
• Basic project management skills.
• 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 applicable to method validation testing and analysis.
• Ability to troubleshoot.