Location: Suffern,NY, USA
The System QA Manager is responsible for creating and maintaining the laboratory's Quality plan that will be compliant with CLSI, CAP and NYSDOH standards for all hospital locations within the Bon Secours Charity Health network. The System QA Manager makes sure that quality standards are followed by all departments, provides technical expertise as needed, and serves as the liaison to external governing entities. ensures that the laboratories and the laboratory staff comply with all required laws and regulations by CLIA, CAP, OSHA, NYSDOH, and any other applicable legislative organizations.
Responsibilities:
* Identifies opportunities and propose improvements, efficiencies, and operational modifications as it relates to the laboratory.
* Responsible for scientific oversight of the laboratory including writing and review of all SOP's.
* Collaborates with the Medical Directors of the Laboratories to create, optimize and enforce the approved Quality Plan.
* Maintains a state of readiness for inspections through regular periodic meetings with all department managers and supervisors, self-inspection checklists and proactive observations.
* 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.
* Collaborates 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 and serve as representative to hospital committees as required or requested.
* Provides regulatory guidance with validating and implementing new methods and technologies.
* Plans, implements, and manages activities related with root cause analysis, corrective actions, and continuous improvement projects.
* Guides and supports validation and/or qualification activities, data analysis, system and process design, and audits.
* Leads, directs, and trains quality associates in their job responsibilities and functions (e.g., responding to event reporting).
* Verifies the test procedures performed and establish the laboratory's test performance characteristics, including precision and accuracy of each test and test system.
* Resolves 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.
* Holds periodic meetings with the Laboratory's management team to assure the lab is inspection ready.
* Performs other duties as assigned.
Qualifications/Requirements:
Experience:
Minimum of 4 years laboratory experience as a Medical Technologist in a CLIA accredited clinical laboratory required. 2 years of quality systems development or quality assurance experience preferred.
Education:
Bachelor's degree in laboratory sciences or related degree required.
Licenses / Certifications:
New York State license as a Clinical Laboratory Technologist required. National registration (NCA/ASCP) preferred.
Other:
Excellent professional communication skills, including verbal, written, and presentation, with a knowledge of Microsoft Office; collaboration skills, with the ability to positively influence others. Strong leadership skills: able to support and demonstrate company mission and perform as a team member and leader.Special Requirements: This position will require travel to other facilities within the laboratory network.