Details
Posted: 20-Mar-25
Location: Valhalla, New York
Categories:
Executive
Job Summary:
The Laboratory Quality Control, Quality Assurance Manager will work directly for the Laboratory's Medical & Quality Directors and be responsible for creating and maintaining a Quality plan which will be compliant with CLSI, CAP and NYSDOH standards. Makes sure that quality standards are being met, from all departments. Provides technical expertise to the laboratory and as needed, serves as the liaison to external governing entities. The Laboratory Quality Control and Quality Assurance Manager ensures that the laboratory and the laboratory staff is in compliance with all laws and regulations that are required by CLIA, CAP, OSHA, NYSDOH, DNV and any other applicable legislative organizations, The Laboratory Quality Control and Quality Assurance Manager is expected to hold regular periodic meetings with the Laboratory's management team to assure the lab is always inspection ready at any moment
Responsibilities:
- Be a proactive leader and identify opportunities and propose Improvements, efficiencies and operational modification as it relates to the laboratory
- Responsible for scientific oversight of the laboratory including writing and review of all SOP's.
- Identify and understand regulatory requirements to ensure the laboratory is in compliance with all applicable laws and regulations pertinent to the management of the laboratory, including applicable CLIA, CAP, NYSDOH, DNV and other requirements and regulations for states in which the lab is licensed
- Collaborates with the Medical Director of the Laboratory to create, optimize and enforce the Quality Plan as it is written.
- Maintains a state of readiness for inspections at all times, through regular periodic meetings with all department managers and supervisors, self-inspection check lists and Proactive observation.
- Supports, implements, and ensures compliance with all departmental and company policies and procedures including but not limited to Quality, Compliance with all regulatory entities and Safety
- Expected to work with all Managers, Supervisors and Employees on meeting the standards in the Quality Plan
- Prioritizes responsibilities, anticipates problems and provides timely and appropriate solutions.
- Ability to liaison with other operational areas.
- Responsible for validating and Implementing new methods and technologies
- Verify the test procedures performed and establish the laboratory's test performance characteristics, including precision and accuracy of each test and test system
- Ensure that the quality management program is maintained by following parameters for acceptable performance for the pre-analytical, analytical and post-analytical testing processes
- Resolve all technical problems with the aid of the technical staff and ensures that remedial action is taken whenever a test deviates from the laboratory's performance standards
- Ensure that all patient results are not reported until corrective actions have been taken and the systems are functioning properly
- Identify training needs and ensures all training Is performed as required
Qualifications/Requirements:
Experience:
4 years laboratory experience as a Medical Technologist in a CLIA accredited clinical laboratory, 2 years of quality systems development or quality assurance (preferred)
Education:
BSMT or BS Degree in one of the life sciences (Biology Chemistry, etc.), Clinical Lab Science, or in Medical Technology State Licensure required.
Licenses / Certifications:
ASCP certification or equivalent is desired
Other:
Special Requirements:Physical Requirements: Physical Activity (please check one box):a~ Sedentary Work (involves sitting most of the time, occasionally walking and standing; requires lifting no more than 10 pounds at a time and/or occasionally lifting or carrying objects) a~' Light Work (involves lifting no more than 20 pounds at a time with frequent lifting or carrying of objects weighing up to 10 pounds; requires moderate mobility to different work locations) a~ Medium Work (involves substantial physical activity and mobility; and lifting no more than 50 pounds at a time with frequent lifting or carrying of objects weighing up to 25 pounds.) a~ Heavy Work (involves some type of manual labor including operating heavy machinery/ equipment or physical labor; requires lifting no more than 100 pounds at a time with frequent lifting or carrying of objects weighing up to 50 pounds)
About Us:
WMC Advanced Physician Services PC
Benefits:
We offer a comprehensive compensation and benefits package that includes:
- Health Insurance
- Dental
- Vision
- Retirement Savings Plan
- Flexible Savings Account
- Paid Time Off
- Holidays
- Tuition Reimbursement