Posted to MedZilla on 2/2/2018

Vero Diagnostics



Company Info:

Vero Diagnostics is a start-up clinical laboratory based in Research Triangle Park, NC looking for a senior Medical Technologist or Clinical Laboratory Scientist with a M.S. degree or higher to join the management and analytical team. This position will report to the Director of Laboratory Operations, and will train to increasing responsibilities for management of laboratory operations as well as analytical activities of the laboratory. The lab currently performs testing for Lyme Disease, and is expanding to include molecular methods for select co-infections in response to physician requests. Job responsibilities include laboratory staffing and workflow, purchasing, regulatory compliance, staff training and competency assessments, QA/QC, new method development/validation, and interactions with physicians, providers, patients, and regulatory agencies. This is an excellent opportunity for an experienced laboratory manager with bench experience in a clinical lab to join an exciting new laboratory and participate in strategic decisions, with great professional upside and autonomy within the lab.


Specific job responsibilities will include but are not limited to:

· Performs high complexity testing or laboratory support activities within the department as required to train staff, meet competency requirements, assist with results turnaround, or to troubleshoot laboratory processes. Proficient in running current Lyme tests (ELISAs and western blots) and developing new molecular methods. This position may serve as a CLIA technical supervisor or general supervisor.

· Work with Director of Laboratory Operations to develop and validate PCR test methods for the co-infection panel.

· Manage SOP documents, including revisions as needed.

· Oversee routine analytical operations, including daily review of assays and weekly equipment/instrument maintenance and calibrations.

· Manage sample accessioning (typically accession samples received for testing, verify test requisition and payments, prepare samples for testing and sample banking, track testing and results release, etc.).

· Manage preparation and release of patient sample reports within the nominal turnaround time of 7‑10 calendar days.

· Identify solutions to problems that may adversely affect test performance or reporting of test results in consultation with Director of Lab Operations or Lab Director if necessary.

· Promotes quality assurance activities, quality control, and CLIA compliance among lab staff. Conduct regular QA reviews, and author QA reports for critical issues.

· Manage inventory and purchasing of lab supplies.

· Manages laboratory projects such as implementation of new procedures, validations, or instrumentation and writes supporting documents for review by Laboratory Director.

· Manage personnel hiring and annual training, including review of training records.

· Interact directly with providers and patients regarding test results and general questions.

· Participates in continuing education and maintains sufficient current education hours to keep certification current, if applicable.

· Meet CLIA standards and all HIPAA requirements, and participate in inspections. Comply with OSHA and the lab facility requirements and safety protocols.

· Prepare applications to New York, Florida, and other states as needed to obtain permit for testing patient samples. Maintain current permits as required by those states.


You should apply for this role if you have earned a M.S. degree or higher, are an experienced medical technologist or clinical laboratory scientist with certification from ASCP or comparable professional organizations, and have some supervisory experience.


· MT, CLS, or comparable certification by ASCP or an equivalent organization highly preferred.

· M.S. degree or higher in medical technology, immunology, molecular biology, biochemistry, or related science.

· Clinical laboratory experience, at least 2 years. Highly prefer experience in immunology and molecular biology specialties.

· Supervisory or management experience preferred; experience may be in an academic environment or clinical lab.

Salary and Benefits:

· Position is full-time (40 hrs/week).

· Annual salary is $60-72k, based on experience.

· Hours are flexible between 7am and 7pm, 7 days a week, as arranged with Director of Laboratory Operations.



CLIA CAP Medical Diagnostics Supervisor Lab Operaions ELISA Western Blot PCR Lyme

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