Specialist, Quality Assurance (MT, MLS)

Regulatory Jobs; Roanoke (VA); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

Regulatory Jobs is hiring for an onsite General Laboratory Supervisor to support Carilion Hospital locations. The role emphasizes CLIA '88 compliance, CAP accreditation standards, proficiency testing enrollment, and quality assurance across pre-analytical, analytical, and post-analytical steps.

You will coordinate inspections, maintain QA/QI plans, assist SOPs, and report quality issues. Requires 3+ years in a laboratory, CLIA supervisor qualification, and MT/MLS certification.

Formación

• Qualification as General Laboratory Supervisor per CLIA '88.
• Minimum of three years in a laboratory setting.
• Experience with QA, statistical quality control, and accreditation requirements.

Responsabilidades

• Support internal inspection processes to ensure regulatory compliance.
• Assist in maintaining QA manuals and quality indicators.
• Coordinate QA initiatives and document reporting of quality issues per SOP.
• Support proficiency testing enrollment and corrective actions when needed.

Conocimientos

Interpersonal communication

Written communication

Laboratory operations

Quality tools

Project management

Analytical skills

Computer skills

Team motivation

Educación

Lab science degree

Descripción del empleo

Support and coordinate efforts that foster quality and ensure that all pre-analytical,analyticaland post-analytical processes are consistent with our company values and mission.

This is an onsite position supporting our Carilion Hospital Locations.

Travel: Up to 25%

Licensing and Accreditation

• Support the internal inspection process of the business unit, associatedlaboratoriesand specimen collection sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements and Quest Diagnostics standards.
• Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards.

Proficiency Testing

• Assist and ensure enrollment and participation in proficiency testing for each test to include Corrective Action when necessary.
• Assist in maintaining a defined instrument-to-instrument, method-to-method, and laboratory-to-laboratory comparison process.

Quality Assurance/Quality

• Improvement Support and assist on monthly Quality Assurance (QA) meetings. Support each department's comprehensive Quality Improvement (QI) plan. Assist in maintaining and monitoring Quality Assurance specific quality indicators.
• Facilitate the preparation,distributionand review of the QA Manual.
• Support the Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes VerificationProgramand other monitoring programs specifically assigned by National Quality Assurance. Quality Assurance Initiatives
• Assist in the prompt and complete reporting of Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP).
• Assist in the complete tracking of revised reports in compliance with the SOP.
• Assist in any other duties as assigned by the Technical Manager.

Required WorkExperience:

• Qualification as General Laboratory Supervisor as defined by CLIA '88required
• At least three years employment in a laboratory setting required
• Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirementsrequired.

Skills:

• Strong interpersonal communication skillsrequired
• Demonstrated strong writing and composition skillsrequired
• Understands clinical laboratory operationsrequired
• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools required
• Able to manage changerequired Organization skillsrequired Project management skills required
• Analytical skills required
• Technical skills required
• Computer skills required
• Able to function in a matrix organization desirable
• Multi-tasking skills desirable
• Demonstrated success in motivating team members to reach objectivesdesirable

Education

• Bachelor's Degree Chemical, physical, biological or clinical laboratory science or medical technology (Required)

Licenses and Certifications

• Certifications Qualification as General Laboratory Supervisor as defined by CLIA '88 (Required)
• MT/MLS required. (Medical Technologist / Medical Laboratory Scientist)