Website admerahealth Admera Health

Advancing Precision Medicine Beyond Diagnostics

Admera Health is seeking an Quality Assurance Manager to join our growing team!

Title: Quality Assurance Manager

Location: South Plainfield, NJ

Responsibilities:

  • Plans, directs and coordinates the efforts of Quality Assurance (QA) team towards maintaining an effective quality system
  • Manages, maintains and improves the QA system to meet the regulatory standards needed by business units (ex. CLIA, CMS, HCS, DOH, etc.)
  • Oversees the review, update and maintenance of all SOP’s and other QA documents
  • Performs regular facility audit to ensure compliance to our quality system and governing regulatory body requirements
  • Executes and upholds all clinical and state license •Communicate any critical compliance risks to senior management
  • Ensures regulatory rules are communicated through corporate policies and procedures
  • Assumes a lead role for the preparation, conduct, and responses to regulatory agency
  • Responsible for the coordination of all laboratory activities to ensure compliance with the laboratory and corporate Quality Systems
  • Assists in the development, notification and implementation of Quality Control Systems
  • Manges all Clinical employee personnel files
  • Assists in the development of training and competency of all clinical employees
  • Monitors compliance with standards established by regulatory and accrediting bodies such as NJ Clinical Laboratory Improvement Amendments and the Centers for Medicare & Medicaid Services
  • Establishes, Maintains and Manages an instrumentation inventory to ensure all CLIA standards are met
  • Assists with the preparation, coordination, and management of regulatory agency inspections

Qualifications:

  • BA/BS, preferably in a scientific discipline or life sciences
  • 3-5 years of relevant experience in a CLIA or CAP regulated environment preferred
  • Knowledge of a high complexity clinical testing environment
  • Must possess the technical and administrative abilities required to carry out routine audits with minimal supervision and to play a supporting role in more complex audits
  • Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management
    alike
  • Ability to verbally communicate effectively with team members and multiple departments

Admera Health focuses on advanced molecular diagnostics, personalized medicine and non-invasive cancer testing. Our goal is to fulfill unmet medical needs with cost-effective tests and accurate analysis that guide patient care by utilizing next generation sequencing technologies and advanced bioinformatics to redefine disease screening, diagnosis, treatment, monitoring, and management. It is our mission to deliver transformative, valuable solutions for patients, physicians, payers, and clinical researchers.

Admera Health employees have a winning attitude and champion innovation, teamwork and accountability through a results-oriented, customer-centric, and fun culture. We offer various health and financial benefits, learning opportunities, competitive compensation, rewarding bonus programs, and a wide range of work/life benefits designed to make your life easier.

For more information, please visit www.admerahealth.com.
To review and apply to our open positions, please visit www.admerahealth.com/careers.

Apply Now