Selection by Eurofirms is a specialized selection company where we look for the best fit between candidates and companies, seeking the welfare of people. We belong to the Eurofirms Group, the first national company in people management.
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.
· 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 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