Quality Assurance Specialist, Laboratory Services EU (España)

Job Purpose/Summary

Quality Assurance Specialist, Laboratory Services in the EU is responsible for the assessment of quality and compliance according to CLIA and CAP requirements, ISO 15189 requirements, GCP, GLP, and CTI Laboratory SOPs.

What You’ll Do

• Author, review, and maintain standard operating procedures (SOP) for the laboratory.
• Provide training and guidance regarding quality and regulatory compliance for laboratory staff.
• Participate in and support risk assessments within the Quality Management System to continuously improve processes.
• Participate in outside qualification audits for vendors supplying services or products, subcontractors, including contract laboratories; resolve and follow-through on any quality issues.
• Conduct in‑study and facility‑based audits, including equipment/instrument qualifications, equipment calibration and maintenance, software validation, and laboratory processes in compliance ...