.Quality Assurance Specialist, Laboratory Services EUJob Purpose/SummaryThe 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 DoAuthor, 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 quality-led sponsor audits.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 BringWorking 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.Fluent in English.Why CTI?At CTI, we recognize that our people are what make our company successful.
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