QA Manager

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Job description

LetsGetChecked is a leading at-home health testing company, with a platform that allows consumers to discover and access personalised health information conveniently, confidentially and accurately. We empower people to take an active role in their health to live longer, happier lives. LetsGetChecked was founded in 2015 and has corporate offices located in New York City and Dublin.

Quality Assurance Manager

The Quality Assurance Manager will work directly with the Laboratory Director, Laboratory Manager, and Departmental Supervisors to create, maintain, and monitor the Quality Management System to be compliant with CAP and CLIA standards. The QA Manager will make sure that quality standards are being met, from all departments. The QA Manager will need to serve as the liaison to external governing entities. The Quality Assurance Manager ensures that the laboratory and the laboratory staff are in compliance with all laws and regulations that are required within and outside the testing state and any other applicable legislative organizations. The Quality Assurance Manager is expected to hold regular periodic meetings with the Laboratorys management team to assure the lab is always inspection ready at any moment.

Responsibilities

* Co-ordinating awareness of the needs and requirements of users and set quality objectives
* Partaking in laboratory meetings, decision making and policy implementation
* Educating and training the laboratory's staff in quality principles and practice
* Ensuring the quality management system on behalf of laboratory management is established, implemented and maintained
* Reporting to laboratory management at QMS meetings on the functioning and effectiveness of the quality management system
* Ensuring that there is a functional document control system controlling all documents (internally generated and from external sources)
* Ensuring that all documents generated adhere to pre-defined templates and that all relevant personnel are trained
* Ensuring that all documents produced comply with the document control system in place.
* Maintaining electronic QMS
* Maintaining Quality Manual
* Ensuring that all sub committee meetings are scheduled, prepared, minuted and actioned
* Ensuring that continual quality improvement is achieved, identifying areas and particular projects where there is the potential for improvement of quality, investigating result, service complaints and incidents and ensuring that effective immediate and follow up actions are taken.
* Ensuring that internal audits of system and process performance are scheduled and performed and that each audit is closed within a desirable time frame.
* Ensuring participation in the evaluation of clinical effectiveness, audit and risk management activities of the parent organisation
* Ensuring that external quality assessments are performed on all tests and addressed at the departmental meetings
* Follow up on external inspections and verify the completion of corrective action as required by the reports of the inspectors.
* To provide information periodically for management quality review.

Requirements

* 5+ years experience working with a QMS in a Clinical Laboratory
* Understanding of Good Laboratory Practices (GLP)/ Good Clinical Laboratory Practices (GCLP), CLIA regulations and CAP requirements
* Experience implementing and maintaining departmental key performance indicators
* Familiarity with assessing, monitoring and evaluating non conformances and corrective actions

Preferred

* Licensed as a Clinical Laboratory Scientist in the state of California

Required Skills

* Strong understanding of how to run a laboratory to achieve maximum efficiency and quality
* Excellent interpersonal, communications, public speaking, and presentation skills.
* Solid working knowledge of budgeting, sales, business development, and strategic planning.
* In-Depth understanding of QC, QA, and statistical analysis.
* Understanding of State, Federal, and Local Regulatory Requirements including CLIA, CAP, and OSHA
* Ability to generate respect and trust from staff and external constituencies.

Benefits

* Healthcare, Dental and Vision Insurance
* PTO
* 401K
* Life Insurance