Clinical Laboratory Supervisor - Aventa Genomics : Job Details

Company Description:

Aventa Genomics is a CLIA-certified clinical molecular laboratory in Orlando, FL. Aventa is a subsidiary of Arima Genomics, a San Diego, CA biotechnology company with a proprietary 3D-genomics technology that reveals the organization of DNA at the cellular level. This technology is the basis of the Aventa FusionPlus test for the identification of gene fusions and rearrangement in patients with solid tumors.

Just like our technology is on another level, so are we. We are self-reflective and accountable self-starters who are tenacious and relentless in the pursuit of excellence.

Our environment is open and collaborative, we invest in each other's growth, and we empower one another. We listen to and value differences in perspective and approach. As a startup, we move fast, adapt to change and are continuously improving ourselves, our processes, and our products. Though we are adaptable we continuously prioritize to stay focused on our vision.

What you will do:

The Clinical Laboratory Supervisor is responsible for regulatory compliance, QC/QA of Molecular tests, performing high complexity NGS testing on patient specimens, and overseeing the duties, credentials, training, and proficiency of the molecular staff. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multi-task, flexibility with schedules, the ability to work independently in a team environment, and strong adherence to quality control and quality assurance procedures and compliance with the laboratory regulations.

The candidate should be an expert in CLIA/CAP/FL requirements. They must be able to adhere to these requirements in daily laboratory production and are expected to teach or train and oversee compliance of junior technologists in their assigned duties.

Duties

• Ensure regulatory compliance for the lab and personnel.
• Perform final QA for Molecular test by reviewing patient and control data, and document according to laboratory quality procedures.
• Perform processing of patient samples using molecular biology protocols governed by standard operating procedures (SOPs) Including Extracting nucleic acids from samples and construct DNA libraries and performing NGS.
• Lead root cause investigation for Non-conformances and Deviations. Recommend corrective actions and ensure these are implemented and documented appropriately.
• Track quality metrics and notice shifts and trends of samples and controls; identify and communicate abnormal data and provide causality and solutions.
• Oversee day-to-day activities of staff members and manage schedule
• Oversee training efforts; provide and create training materials.
• Perform daily maintenance and monitor the laboratory equipment.
• Assist with the development and upkeep of SOPs.
• Document activities and results in the LIMS and worksheets.
• Perform environmental health and safety functions, as needed.
• Ability to work seated for approximately 20% of a typical working day. Ability to work standing for approximately 80% of a typical working day.
• Ability to lift up to 25 pounds for approximately 5% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.

Minimum Qualifications

• Have a Supervisor License in the Molecular Pathology specialty from the Florida Board of Clinical Laboratory Personnel.
• 3+ years of experience as a Licensed Clinical Lab Supervisor.
• Possession of an MB (ASCP) or SMB (ASCP) certification
• Expert knowledge of laboratory concepts and applications as well as laboratory safety and CLIA/CAP/FL regulatory requirements.
• Prior hands-on experience performing NGS assays.
• PhD, Masters, or Bachelor's Degree in a chemical, physical, biological or clinical laboratory science or medical technology with requisite number of years of experience as a Molecular Technologist, pursuant to Florida State rule 64B3-5.002
• Technically proficient in basic molecular techniques and related equipment.
• Proficient in Microsoft Office programs, such as Word, Excel, and PowerPoint.
• Authorization to work in the United States without sponsorship.

Job Type: Full-time

Ability to Commute:

• Orlando, FL 32827 (Required)

Ability to Relocate:

• Orlando, FL 32827: Relocate before starting work (Required)

Work Location: In person