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