The General Supervisor is responsible for ensuring that samples are tested promptly, accurately, and proficiently, while adhering to applicable CAP and CLIA regulations. Perform essential functions such as: management of workflow of samples and promoting effective communication with Lab Management and Lab Personnel. The general supervisor must provide day-to-day processing supervision and must be accessible while testing is being performed.
Essential Responsibilities/Duties:
Responsible for providing day-to-day processing supervision of high complexity test performance by testing personnel.
Ensure each employee has the necessary tools and supplies to complete their job in an efficient high-quality manner.
Ensure proper communication to technical lab upon any changes to protocol or company policies.
Exhibit leadership skills such as: communication, adaptability, critical thinking, teamwork, time-management, and interpersonal skills.
Responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance is maintained.
As applicable, under Technical Supervisors directions, assist training and documenting competency assessment of all laboratory employees in compliance with regulating bodies (CAP, CLIA, etc.).
Assist maintaining all compliance documentation in accordance with regulating bodies (CAP, CLIA, etc) including cleaning logs, maintenance logs, IQ/OQ/PM's etc.
Collaborate with the Quality Analyst on writing, updating, and maintaining SOP manual.
Performing sample processing, DNA extraction and PCR. Ability to run KingFisher Flex, Veriti Pro, Accufill and QuantStudio 12K and 5.
Continuously monitor and develop workflow processes as needed to ensure timely turnaround, efficiency, and quality of specimen processing.
Provide technical oversight to lab personnel who perform testing procedures.
Strong understanding of procedures, SOPs, QC/controls to ensure accurate and valid data is reported.
Fully capable of identifying problems that may adversely affect testing performance or reporting of results by immediately taking appropriate action. (i.e. taking an instrument of out of production if maintenance and/or repair is requir3ed, initiating any corrective action plans needed, etc.)
Responsible for supporting menu validations and additional duties as required (i.e. validations, AMR, lot to lot verifications, internal audits, document control).
Ability to perform basic accessioning in pre-analytical operations as needed: requirements for Patient Identifiers (PID), auditing and communicating client manifest issues, identifying specimens categorized as non-compliant, acceptance/rejection of patient specimens, and creating cases or exception and send out orders.
Qualifications:
Education -
Clinical testing personnel must possess a current license issued by the state in which the laboratory is located, if such licensing is required; and meet the following educational requirements:
60 semester hours or equivalent from an accredited institution that, at a minimum, includes either 24 semester hours of medical laboratory technology courses, OR 24 semester hours of science courses that include six semester hours of chemistry, six semester hours of biology, and 12 semester hours of chemistry, biology, or medical laboratory technology in any combination.
Completion of a clinical laboratory training program approved or accredited by the ABHES, NAACLS, or other organization approved by HHS (note the that this training may be included in the 60 semester hours listed above).
At least 1 year laboratory training or prior experience, or both in a high complexity laboratory testing environment.
Competencies/Skills -
Knowledge of clinical laboratory services.
Technical knowledge to monitor lab operations.
Strong verbal and written communication skills.
Ability to work independently and strong attention to detail.
Strong problem-solving skills
Experience -
1-year previous leadership experience required
2-4 years training and experience in high-complexity molecular testing required; to align with CAP and state specific requirements.
Comprehensive understanding of QA/QC to ensure precision and accuracy of results.
Proficient in molecular laboratory techniques and processes, including but not limited to pipetting.
Borad understanding of sterile techniques, contamination control, and unidirectional workflow necessary for a PCR lab.
Thorough understanding of quantitative PCR workflow and data analysis as it relates to troubleshooting.
Prior experience in assay development, instrument verification and/or validation required.
Certifications/Licenses -
ASCP, AMT, or other organizations preferred unless required by the State in which the laboratory is located.