Indirectus, LLC

Senior Quality Assurance Manager

Job ID 2018-1888
Job Locations
US-DC-DC Metro
Category
Public Health
Type
Full-Time/Regular

Overview

The Senior Quality Assurance Manager will manage and solve quality problems, oversee the preparation of procedures and audits, analyze quality data, apply quality tools and fundamental methods for process control, and report regularly on quality issues.

 

*This position is contingent upon contract award*

Responsibilities

  • Provides development of project Software Quality Assurance Plan and the implementation of procedures that conforms to the requirements of the contract.
  • Provides an independent assessment of how laboratory processes are being implemented relative to the defined process and recommends methods to optimize the new and existing processes. 
  • May be responsible for all activities involving quality assurance and compliance with applicable regulatory requirements.
  • Conducts audits and reviews/analyzes data and documentation in accordance with established CLIA, CLIP, CAP, AABBB, and FDA regulations.
  • Oversees all phases of pre-test, test, and post-test quality processes for both clinical laboratories and research regulated environments.  

Qualifications

  • At least five (5) years of experience in a quality management role.
  • BS in biological science required, MS preferred.
  • Certification as Medical Technologist from ASCP or CSLMS.
  • Demonstrated expertise in quality management. 
  • Experience with CAP re-accreditation inspections and US FDA audits.
  • Excellent MS Office skills.
  • Security Clearance required.

 

 

 

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