Manager, Clinical Laboratory Quality Systems

The Clinical Laboratory Quality System Manager is responsible for many quality aspects in the clinical laboratory, including developing and maintaining the quality management system, ensuring compliance with all regulatory requirements and non-conforming event management. The Manager, Clinical Laboratory Quality Systems monitors effectiveness of the Quality Management Program and provides visibility through data and metric reporting.

Job Relationships

Reports to the Director of Laboratory

Principal Responsibilities

  • Build and develop clinical laboratory Quality System Program using CLSI model. Creates plans, policies, processes, and procedures in accordance with federal and state guidelines, and monitors the Proficiency Testing program, policy development, and training.
  • Evaluate policies and procedures to ensure the clinical laboratory meets respective standards and regulations; supports regulatory registrations, inspections, reporting and formal communications with CLIA, CAP, COLA,FDA and the state of Illinois.
  • Develop laboratory-based metrics to measure efficacy of the quality system and prepares periodic metrics reporting for management oversight.
  • Review and document non-conforming events, conduct investigation, perform root cause analysis, and development of corrective and preventive actions.
  • Provide assessment, quality input and guidance, investigational support, and resolution for end-user feedback, interacts with management for follow-up; assists in gathering documentation.
  • Support and comply with Springfield Clinics Quality Management System policies and procedures.
  • Comply with the Springfield Clinic incident reporting policy and procedures.
  • Adhere to all OSHA and Springfield Clinic training & accomplishments as required per policy.
  • Provide excellent customer service and adhere to Springfield Clinic's Code of Conduct and Ethics Standards.
  • Perform other job duties as assigned.

Education/Experience

  • Bachelor's degree in a laboratory science.
  • Two or more (2+) years of experience in a quality-oriented environment.
  • One or more (1+) year of experience with quality management systems or certifications in quality assurance.
  • One or more (1+) years of experience with audits or inspections by regulatory bodies, such as CAP, NY or FDA.
  • One or more (1+) years of experience working with a Laboratory Information System, and past experience with HIPAA regulations

Knowledge, Skills and Abilities

  • Basic computer skills to include Internet navigation, Email usage, and word processing.
  • Proficient in Microsoft Office to include Excel, Word and Powerpoint.
  • Demonstrated ability to collaborate across functions and with both internal and external stakeholders, and to communicate ideas and opinions in a proactive and professional manner.
  • Demonstrated understanding of specific regulatory requirements for clinical laboratory operations,
  • Working knowledge of FDA, CLIA, COLA and CAP.
  • Demonstrated ability to perform the Essential Duties of the position.
  • Exceptional written and verbal communication skills.
  • Strong attention to detail, organization, and record-keeping skills.

Working Environment

  • Moderate travel is required to adequately perform job duties.
  • Work is performed in both office and clinical environments including computer and phone use.
  • Requires walking and standing activities to assist staff in clinical areas, as well as have the ability to lift or exert force up to 25 pounds.
  • Comfortable with a fast paced, high intensity environment.

PHI/Privacy Level

HIPAA1


Category

Quality Control Systems Managers


Education

Bachelor's Degree


Experience

2 years


Job type

Full time

Posted
10/02/2021
Salary Range
$57,000.00 - 106,000.00
per Year
Salary range estimated by
Location
Springfield, IL 62701, US
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