Admera Health is seeking a Quality Assurance Manager to join our growing team!
Title: Quality Assurance Manager
Location: South Plainfield, NJ
Admera Health is a leading precision medicine company providing a suite of high-integrity pharmacogenomics (PGx) solutions, diagnostic testing, and biopharmaceutical research services. PGx, the study of how genes affect a person’s response to drugs, combines the fields of pharmacology and genomics to develop effective, safe medications and dosing recommendations tailored to a person’s genetic makeup. PGx testing may help reduce adverse drug reactions (ADRs), which some estimates place as the fourth leading cause of death – resulting in more deaths than lung disease, diabetes, AIDS, pneumonia, and accidents. For every healthcare dollar spent on medications, an additional 50% is spent on addressing ADRs. Admera Health’s flagship product, PGxOne™ Plus, is a comprehensive test built on the foundation of enabling smarter and safer medication management. The test incorporates next-generation gene sequencing design applications and expert data curation to deliver biological systems based medically actionable results. In addition to PGx services, Admera Health leverages existing knowledge and infrastructure to offer related clinical services and robust biopharmaceutical genomics solutions to researchers worldwide.
- Plan, direct 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
- Ensure regulatory rules are communicated through corporate policies and procedures
- Assume 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
- Assist in the development, notification and implementation of Quality Control Systems
- Mange all Clinical employee personnel files
- Assist in the development of training and competency of all clinical employees
- Monitoring compliance with standards established by regulatory and accrediting bodies such as NJ Clinical Laboratory Improvement Amendments and the Centers for Medicare & Medicaid Services
- Established, Maintains and Manages an instrumentation inventory to ensure all CLIA standards are met
- Assisting with the preparation, coordination, and management of regulatory agency inspections
- 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 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.