About Us
Would you like to be part of a fast-growing team that believes no one should have to succumb to viral cancer? Naveris, a biotech startup based near Boston, MA, is looking for a Clinical/General Supervisor team member to help us develop our next great product for patients at risk of developing viral cancers. Our flagship test, NavDx, is a breakthrough blood-based DNA test for HPV cancers, clinically proven and already trusted by hundreds of physicians and institutions across the U.S.
Opportunity
The purpose of the Laboratory General Supervisor is to serve as a Clinical/General Supervisor under CLIA 42 CFR 493.1449 regulations for a molecular diagnostics lab. You will assist the Clinical Laboratory Director in day-to-day personnel, workflow, quality control, and equipment management. You are responsible for ensuring that the tests meet all regulatory requirements and coordinating with the laboratory staff to review data for accuracy and issue tests reports in a timely manner.
Job Responsibilities
Reporting to the Chief of Clinical Operations, you will be supporting the Clinical Lab department in ensuring accuracy and that the tests meet all regulatory requirements.
Duties include:
- Provide leadership and directs a team of technologists through positive communication and support.
- Train new personnel with regard to technical and operational procedures
- Ensure all laboratory members are proficient in assay processing including biannual (first year and subsequent annual competency training)
- Organize specimens required to be run
- Review data for concordant analysis, write-up results, and file data with the assay tested under competency runs
- Annually evaluate and document the performance of all testing personnel
- Create daily/weekly technologist schedule for molecular diagnostic assays
- Setting-up equipment and resources for the laboratory
- Monitor examinations to ensure that acceptable levels of analytic performance are maintained and meet TATs
- Ensure that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specification
- Report quality issues directly to the Clinical Laboratory Director
- Track proficiency testing for the validated assay in the laboratory that includes calendar tracking, and following through concordance analysis and finalizing all documents in the database for any future inspections
- Maintain all Quality Management System on instrument maintenance programs, i.e. preventative maintenance, cleanliness and maintains records of service in compliance CAP
- Maintain and manage daily performance and workload distributed throughout the laboratory
- Review issues regarding problem cases with Clinical Laboratory Director to get direction for troubleshooting and next step directions
- Work with the lab team to monitor and maintain inventory of supplies, place orders of materials
- Participate with Clinical Laboratory Director in managing all governmental and regulatory audits
- Manage and monitor Quality Control (QC), Quality Assurance (QA), Safety and Inspection practices to assure compliance with CLIA and MA regulations
- Develop, implement and maintain SOPs as per CLIA and MA regulation
- Maintain a flexible schedule to meet laboratory goals such as performing laboratory analysis on clinical specimens using established laboratory procedures. These duties may include but are not limited to; processing of specimens, performance of moderate, and highly complex analytical testing, establishing performing and documenting quality assurance, quality control, equipment maintenance, and accurately documenting all work performed.
Requirements
- Bachelor’s degree or higher in a biological science or chemistry.
- At least of least 2 years of laboratory training and 6 years experience in high
- complexity testing; or 1-3 years as a General Supervisor in medical devices or
- bio/pharma OR Medical Laboratory Technician (MLT(AAB)), AAB ; 2, Medical Laboratory
- Scientist (MLS), ASCP certification.
- History of developing and maintaining controlled procedures.
- Ability to work independently in an extremely fast-paced, dynamic environment
- Must be a team player with good interpersonal skills
- Excellent problem-solving, organization, and communication skills.
- Proficient in Microsoft Office Suite
- Able to be onsite at our Waltham, MA laboratory
Compliance Responsibilities
Health Insurance Portability and Accountability Act (HIPAA) is a federal law that describes the national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. All roles at Naveris require compliance with legal and regulatory requirements of HIPAA and acceptance and adherence to all policies and standards at Naveris. Personnel acknowledges they are personally responsible for reporting any suspected violations or abuse and are required to complete HIPAA training when joining the company.
Why Naveris?
In addition to our great team and advanced medical technology, we offer our employees competitive compensation, work/life balance, remote work opportunities, and more!
Naveris is an Equal Opportunity Employer
Naveris is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We don’t just accept differences – we celebrate and support them. We do not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
