EU Laboratory QA Specialist — Quality & Compliance

CTI Clinical Trial Services; Bilbao; On-site; EUR 45,000 - 65,000; Full time

Job summary

CTI Clinical Trial Services is seeking a Quality Assurance Specialist, Laboratory Services EU in Bilbao, Spain. The role focuses on ensuring quality and regulatory compliance across CLIA/CAP and ISO 15189, including audits, SOP development, and CAPA implementation.

The ideal candidate will have lab QA experience, experience with instrument qualification and software validation, and strong analytical skills to support regulatory inspections and data integrity.

Qualifications

• Author and maintain SOPs for laboratory operations.
• Ensure compliance with CLIA, CAP, ISO 15189, GXP standards.
• Lead audits of vendors, contracts, and in-house processes.
• Support regulatory inspections and CAPA activities.
• Maintain organized QA records and archiving.

Responsibilities

• Develop and review QA documentation and SOPs for lab activities.
• Train staff on quality systems and regulatory requirements.
• Perform risk assessments and implement corrective actions.
• Conduct internal and supplier audits for quality issues.
• Inspect and validate equipment qualifications and calibration.
• Review study protocols, reports, and scientist contributions.
• Report quality issues to QA leadership and CTI management.
• Contribute to investigations of nonconformances and CAPAs.

Skills

QA & regulatory compliance

CLIA/CAP knowledge

ISO 15189

GCP/GLP

SOP authoring

Internal audits

Data integrity & 21 CFR Part 11

Analytical thinking

Teamwork

Attention to detail

Education

Bachelor’s Degree or equivalent

SQA/CQA certification

CLIA/CAP inspection experience

Tools

Instrument qualification

Calibration & software validation

Electronic data systems (Part 11)

MS Office (Excel, Word, Outlook, PowerPoint)

Job description

CTI Clinical Trial Services is seeking a Quality Assurance Specialist, Laboratory Services EU in Bilbao, Spain. The role focuses on ensuring quality and regulatory compliance across CLIA/CAP and ISO 15189, including audits, SOP development, and CAPA implementation.

The ideal candidate will have lab QA experience, experience with instrument qualification and software validation, and strong analytical skills to support regulatory inspections and data integrity.