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HalioDx Job Offer

Quality Manager (F/ M)

Start of mission:
26.12.2019
Job city:
Richmond, Virginia
Type of contract:
CDI

Job description

You will support and coordinate efforts that foster quality and ensure that all pre-analytical, analytical and post-analytical processes are consistent with our company values and mission.

JOB RESPONSIBILITIES
  • Licensing and Accreditation Support the inspection process of the laboratory and specimen collection site to ensure compliance with applicable federal, state, and local regulations, Clinical Laboratory Improvement Amendments (CLIA) accreditation requirements and HalioDX standards.
  • Assist in maintaining a defined instrument-to-instrument, method-to-method, and laboratory-to-laboratory comparison process.
  • Quality Assurance Improvement Support and assist on monthly Quality Assurance (QA) meetings.
  • Assist in maintaining and monitoring Quality Assurance specific quality indicators.
  • Facilitate the preparation, distribution and review of the QA SOPs.
  • Assist in the prompt and complete reporting of Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP).
  • Assist in the complete tracking of revised reports in compliance with the SOP.
  • Support the US team with the Corporate Quality Management System (SOPs, non-conformities, CAPA), Database Changes Verification Program, Best Practice Team Initiative.
  • Assist in any other duties as assigned by the Director, Quality Assurance.

Profile

JOB REQUIREMENTS
 
Education

Bachelor's degree (chemical, physical, biological or clinical laboratory science or medical technology) required Certifications Qualification as General Laboratory Supervisor as defined by CLIA '88 required.

Work Experience
  • At least three years employment as QA manager in a CLIA laboratory, ideally with NY license
  • Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements required.
Competencies
  • Strong interpersonal communication skills required
  • Demonstrated strong writing and composition skills required
  • Demonstrated success in motivating team members to reach objectives desirable
  • Strong influencing skills desirable Business Process Skills
  • Understands clinical laboratory operations required
  • Able to affect Quality Improvement through problem solving skills and knowledge of quality tools required
  • Able to manage change required
  • Organization & project management skills required
  • Analytical & technical skills required
  • Computer skills required
  • Able to function in a matrix organization desirable
  • Multi-tasking skills desirable
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.