Position SummaryThe Supervisor, Molecular Training and Operations is responsible for the technical components of the Molecular Lab within the clinical business.
Job Responsibilities- Provides technical oversight of protocol execution and hands-on training for the molecular team by developing technical training program modules for current and new assays. Ensures that all team members are provided with complete process and theory training.
- Works closely with the molecular team as well as external vendors to provide support in technical troubleshooting on instruments and testing protocols.
- Works closely with cross-functional team members during new product transfer to ensure that all quality and operational details are discussed and implemented during validation.
- Focus on the maintenance and operation of protocols and instrumentation, as well as planning the arrival and placement set up of any new or relocated equipment.
- Work closely with the quality and regulatory teams to performance qualify any new or relocated equipment.
- Support compliance to all applicable regulatory and standard requirements (FDA, CLIA, NYS, CAP, ISO, etc.).
- Consult with the Laboratory (Medical) Director and other professionals on staff, as needed.
- Make recommendations regarding hiring, discipline and promotion of subordinates; authorizes leave and overtime; evaluates and rates employee performance.
- Maintain confidentiality of all patient information in accordance with federal, state and local guidelines and regulations.
- Develop, train and mentor staff.
- Accepts other duties as assigned.
- Supports the general supervisor in achieving compliance with FDA, CLIA, CAP, NYS DOH and ISO 15189.
- This position has been delegated the responsibility of assessing employee competencies. Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.
- Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting, and maintaining records of patient test results.
- Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
- Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations, and maintenance performed.
- Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance.
- Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director.
- Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
- Perform high complexity testing under the onsite, direct supervision of a general supervisor as defined in the CLIA regulations.
Required Qualifications- Bachelor's or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
- 4+ years lab experience, including 2 years of high complexity patient testing, 1 of which is in Molecular Pathology methods.
Preferred Qualifications- Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
- Previous leadership experience in a clinical laboratory setting
- Experience with PCR, microarray, fragment analysis, Sanger sequencing, and Next Generation Sequencing preferred.
- CLSp (MB), MB(ASCP) certification preferred.
Physical Demands- Must possess the ability to sit, stand, and/or work at a computer for long periods of time.
- May have exposure to blood-borne pathogens, extreme temperatures, high noise levels, fumes and bio-hazardous material/chemicals including formalin in the lab environment.
- Visual acuity and analytical skill to distinguish fine detail. Ability to pass a visual color discrimination test.
Required Training- All job-specific, safety, and compliance training are assigned based on the job functions associated with this position
Other - This position may require periodic travel and some evenings, weekends and/or Holidays.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
