Quality Assurance Specialist, Laboratory Services EU

CTI Clinical Trial Services; Bilbao; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

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

Ausbildung

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)

Jobbeschreibung

Position:Quality Assurance Specialist, Laboratory Services EU

Location:Bilbao, Spain

Job Id:183-22

# of Openings:1

Quality Assurance Specialist, Laboratory Services EU

Job Purpose/Summary

The Quality Assurance Specialist, Laboratory Services 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 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 with QA SOPs.
• Conduct reviews of protocols, final reports and contributing scientists reports, when applicable.
• Effectively report quality issues to supervisor, and CTI Laboratory management, as appropriate.
• Provide input for process investigations, nonconforming quality events, client concerns and the associated CAPA plans.
• Support inspections and help ensure laboratory maintains current federal, state, and local licensure and accreditation (as applicable)
• Support regulatory authority inspections
• Maintain properly indexed quality assurance records. Assure all QA records are up-to-date and accurate and compile the appropriate records for archiving.
• Attend pre-initiation, pre-planning, or operational team meetings as needed.
• Participate in quality projects as assigned
• Promote strong relationships with CTI sponsors.

What You Bring

• Working knowledge of clinical laboratory regulations (e.g. CAP/CLIA), ISO 15189, and licensing requirements
• Working knowledge of instrument/equipment qualification, calibration, and software validation
• Working knowledge of quality assurance GLP GCLP best practices
• Knowledgeable with electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, QC, etc.
• Must possess excellent analytical, critical thinking, oral and written skills
• Well organized and ability to meet deadlines
• Ability to work independently and within a team environment
• High level of attention to detail
• Proficient in MS Excel, Word, Outlook, and PowerPoint
• 2 years of related experience in a clinical laboratory in a Quality Assurance role
• Bachelor’s Degree or equivalent combination of education and experience
• CLIA and/or CAP laboratory inspection experience
• SQA, CQA or other quality related certification

Why CTI?

At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.

For that reason, we treat our team members with the respect they deserve, and our numbers show it:

• We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
• We value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
• We think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
• We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
• Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

CTI Clinical Trial and Consulting Services
Filipa Magalhães
www.ctifacts.com