Quality Assurance Manager

Company: ClinLab Staffing
Location: South Plainfield
Posted on: April 10, 2021

Job Description:

Quality Assurance ManagerSouth Plainfield, NJ
**CAP/CLIA experience required** Responsibilities: -- Plan, direct and coordinates the efforts of Quality Assurance (QA) team towards maintaining an effective quality system. -- Manages, maintains and improves the QA system to meet the regulatory standards needed by business units (ex. CLIA, CMS, HCS, DOH, etc.). -- Oversees the review, update and maintenance of all SOP's and other QA documents. -- Performs regular facility audit to ensure compliance to our quality system and governing regulatory body requirements. -- Executes and upholds all clinical and state license -- Communicate any critical compliance risks to senior management. -- Ensure regulatory rules are communicated through corporate policies and procedures. -- Assume a lead role for the preparation, conduct, and responses to regulatory agency. -- Responsible for the coordination of all laboratory activities to ensure compliance with the laboratory and corporate Quality Systems -- Assist in the development, notification and implementation of Quality Control Systems. -- Mange all Clinical employee personnel files. -- Assist in the development of training and competency of all clinical employees. -- Monitoring compliance with standards established by regulatory and accrediting bodies such as NJ Clinical Laboratory Improvement Amendments and the Centers for Medicare & Medicaid Services -- Established, Maintains and Manages an instrumentation inventory to ensure all CLIA standards are met. -- Assisting with the preparation, coordination, and management of regulatory agency inspections Qualifications: -- BA/BS, preferably in a scientific discipline or life sciences. -- 3-5 years of relevant experience in a CLIA or CAP regulated environment and knowledge of a high complexity clinical testing environment is preferred

• -- Must possess the technical and administrative abilities required to carry out routine audits with minimal supervision and to play a supporting role in more complex audits.

Keywords: ClinLab Staffing, New York , Quality Assurance Manager, Executive , South Plainfield, New York