Eurofins Viracor LLC is an equal opportunity employer and encourages individuals from all backgrounds to apply. By submitting your application, you acknowledge and agree to the following conditions:Drug Screen: Successful candidates will be required to pass a standard drug screen as part of the pre-employment process.Background Check: A thorough background check will be conducted for all potential employees. This may include, but is not limited to, criminal history, education verification, and employment history.Visa Sponsorship: Eurofins Viracor LLC does not sponsor employment visas. All candidates must have the legal right to work in Lenexa, KS without requiring sponsorship. Unless approved by HR and supporting parties.Basic Function and Scope of Responsibility:  The Quality Specialist is primarily responsible for supporting processes for the Clinical Laboratory at Viracor with a focus on maintaining CLIA, CAP and NYSDOH accreditation. The role requires expertise in managing, facilitating and improving processes integral to the Quality Management System (QMS).Essential Job Duties:Level I:Manages one or more of the Quality processes (Training, Competency, Critical Materials, Notifiable Disease Reporting, Proficiency Testing, Non-conforming Events, Deviations, and/or Change Management) by demonstrating the following responsibilities:Establish and define new or updated processes and verify as necessary with little direction from management.Ensure updates to processes and SOPs when updates to regulations/standards are published.Assist management personnel in developing and reviewing technical and operational policies and procedures.Provide continuous mentoring and coaching to less-experienced Quality Coordinators or peers.Ensure and enhance compliance to established quality process requirements.Review documents and records for GDP.Assist in developing methods for compliance to GDP.Provide consultation and direction to ensure processes are implemented at the highest standard.Demonstrates high proficiency in software programs or tools used in Quality.Develops updates to processes/procedures, performs validation of updates, edits SOPs, trains and establishes good working relationship with other associates and vendors, when applicable.Advises and assists management on QMS development and review.Coordinates efforts to effectively work with others in a way that is productive and promotes teamwork and process improvement.Assists in facilitating the Non-Conforming Event/Corrective Action Preventive Action processes, including evaluating root cause analysis assessments to ensure they accurately identify root cause so that elimination or correction of the problem will prevent recurrence.Participates in continual quality improvement projects company-wide and conduct small projects within the department to successful conclusion.Reviews credentials and evaluates qualifications for clinical laboratory associates.Performs and/or assists with other duties as assigned.Level II – Fully meets responsibilities of Quality Specialist I, plus:Reviews and assesses instrument and equipment maintenance and function check records at least monthly, with delegated approval authority as designated by the Laboratory Director.Reviews Deviations, Change Management Forms, Non-conforming Events and Corrective Actions/Preventive Actions for completeness. Closes NCEs with delegated approval authority as designated by the Laboratory Director.Submits Proficiency testing results for formal events, reviews Proficiency testing results for assay performance, communicates PT outcomes with assay supervisor/manager and Laboratory Director, and initiates NCE investigations as necessary. Reports external Proficiency Testing results within applicable timeframe.Reviews and assigns delegations as requested including management of requests for trainers or qualified personnel.Manages competency content, as required.Performs and/or assists with other duties as assigned.
