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CLS, Quality Assurance Specialist

Employer
Medical Science & Computing (MSC), a Dovel company
Location
Bethesda, Maryland
Start date
Sep 26, 2022

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Discipline
Quality, Quality Assurance, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital
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Job Details

We are currently searching for a CLS (Clinical Laboratory Scientist), Quality Assurance Specialist to support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is onsite in Bethesda, MD.

Duties & Responsibilities
  • Participate in planning and coordinating the Department's comprehensive quality assurance program in accordance with the requirements of regulatory and accrediting organizations; the policies, practices, and procedures of the NIH and state of the art practices in laboratory medicine, medical research, patient care and medical training.
  • Participate in the development, implementation and coordination of goals, activities and systems in the department's Quality Assurance Program to ensure compliance with Federal laws and with accrediting agencies' requirements.
  • Develop and implement departmental quality management standard operating procedures (SOPs), policies and instructions including the Department's Quality Assurance Plan, improvement and corrective action plans, inspection and assessment protocols, records management plans, and computer systems validation. Some of these policies address internal audits and error and accident reports.
  • Develop, implement and coordinate departmental policies for product recalls, error and accident reports, personnel job specific training requirements, personnel competency assessment, and internal audits.
  • Develop written procedure manuals.
  • Ensure manuals are kept current and coordinate the annual update and review of Service and Departmental policies which define the standards for work processes and the interpretation of laboratory reports; develop equipment and maintenance procedures to ensure that equipment and ancillary systems are capable of consistently operating within established limits and that tolerances and schedules exist for equipment monitoring, calibration and maintenance.
  • Develop and implement procedures concerning fire, disaster, and safety; monitor compliance with these procedures; and conduct in-service training sessions.
  • Participate in or conduct evaluations and studies of department operations to ensure compliance with regulatory requirements of accrediting organizations; HHS, NIH and Clinical Center policies, procedures and practices; and state of the art practices in patient care and laboratory quality management.
  • Advise the Laboratory Manager and the Quality Manager concerning all regulatory practices and compliance matters and on the use of resources, reorganizing work and revising procedures to ensure quality improvement and compliance with regulatory agencies.
  • Work directly with section leadership, technical staff and senior staff in the implementation of new or changing programs and policies (e.g., in response to CLIA88 or CAP) involving staffing, training, quality assurance/improvement (QA/I) approaches and reports and preparation for inspections.
  • Provide consultation to all Service Chiefs (MDs), Supervisory Medical Technologists (Chief Technologists) and Team Leaders in the program for the design, development, implementation, administration, supervision over and compliance with the QA/I program as required by accreditation organizations to ensure Quality Assurance Program reviews comply with regulatory agency standards.
  • Assist in coordinating self-inspections for accreditation from the CAP on alternate years and with the preparation of laboratory readiness for inspections and the responses to the on-site inspection; assist in the preparation of written responses for the CAP Lab General Checklist.
  • Develop policy and coordinate work related changes with other hospital departments; i.e., patient care physicians, Nursing, Outpatient Services, Transfusion Medicine, etc. and responds to the recommendations from these departments.
  • Inform department personnel of changes in policy and procedures through memoranda and/or meetings and ensures that written standards of procedure and policy are adhered to by the staff with additional responsibility for the training and enforcement of these standards.
  • Present training sessions on quality management of clinical laboratories, technical information and management theory, and assists in conducting discussion sessions for first line and senior supervisors on a variety of management issues. Ensures that each employee is provided with the necessary SOPs to perform assigned duties and that the employee is adequately trained for performing that particular procedure and the employees' competency in that procedure is assessed annually.
  • Provide guidance to patient-care physicians on specimen collection and handling techniques and the implementation and limitations of test procedures. Reviews and ensures the accuracy of information distributed to patient care providers and provides this information through presentations, scheduling and chairing meetings around a particular patient care topic and preparing articles for nursing bulletins.
  • Ensure that all record keeping systems (manual and automated) comply with Clinical Center and regulatory guidance.
  • Participate in the design and implementation of an internal audit system to evaluate wait times in the outpatient phlebotomy services, turnaround times for result delivery, number of cancelled specimens and occurrences or sub-par performance due to deviations from practice standards, and the number of safety incidents, as well as other quality indicators.
  • Participate in the oversight of incident reports filed by or against the department in the hospital’s electronic incident reporting system. Assist in tracking filings to identify recurrent issues that may indicate a systematic problem that needs to be addressed. Analyze data from the Quality Assurance Program, used by nurses and physicians to document problems. Provide documentation in the to outline specifics of the occurrence and determine if the incident reflects a legitimate failure of service.
  • For the proficiency testing programs, receive and distribute unknowns, collects and reviews results, and submits results to outside agencies. Maintain files, review and compare performance to referee and peer participants, investigate discrepancies, and institute changes to correct deficiencies. Review reports submitted by Services for appropriate responses and corrective action.
  • Prepare reports to monitor laboratory operations and personnel usage to identify operational problems and to compare against like organizations for benchmarking. Prepare and oversees productivity measurements that monitor test procedure performance characteristics.
  • Serve on NIH Committees, as a representative for the program; collaborate with NIH and researchers and medical staff regarding such issues as quality assurance, process improvement and accreditation.
  • Perform all other related duties as assigned.
  • This is an essential worker position.\

 

Requirements
  • Bachelor’s Degree in a science-related discipline and certification as an MT (ASCP) or similar.
  • One (1) to three (3) years of experience performing various laboratory quality assurance activities such as, but not limited to, proficiency testing (PT) monitoring (not just PT test performance); instrument/method calibrations, validation and QC monitoring, quality assurance indicator data collection and monitoring, etc.
  • Two (2) to five (5) years of experience in clinical laboratory technical supervision may be substituted for the above quality assurance experience requirement.
  • Strong communications skills, both oral and written.
  • Excellent organizational and time management skills
  • Strong computer skills
  • Ability to lift 10 – 30 pounds.
  • Excellent hand-eye coordination.

 

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.

 

 

Company

Medical Science & Computing (MSC), a Dovel company, is a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. The Dovel Family of Companies combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management. 

MSC has long supported Federal health organizations like the National Institutes of Health (NIH) and applies deep understanding of missions, goals, and operations to discover and implement innovative approaches for streamlining and disseminating research efforts, enhancing knowledge sharing, and improving public health. 

Together, Dovel and MSC offer a diverse set of complex biomedical, scientific, and technology services, coupled with attentive and purpose-driven program management to serve mission critical organizations and drive meaningful change in the world.

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Website
Location
11300 Rockville Pike Suite 1100
Rockville
MD
20852
United States
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