Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- The Laboratory Manager serves under CLIA regulations as the Technical Supervisor.
- The Laboratory Manager is responsible for the technical and scientific oversight of the laboratory.
- The Laboratory Manager is not required to be on site at all times while testing is performed; however he or she must be available to the laboratory on an as needed basis to provide on-site, telephone or electronic supervision.
- The Laboratory Manager should also be available to perform and release results of laboratory testing as necessary.
- Must be proficient and experienced in hosting COLA audits.
- To ensure subject safety at all times
Main Tasks and Responsibilities:
- Accessible to the laboratory to provide on-site, telephone, or electronic consultation
- Be available to lead the Lab during COLA and other regulatory audits.
- The laboratory operates 7 days per week on an as-needed flexible schedule. Weekends duties will be shared, but availability on the weekends is needed.
- Selects the test methodology that is appropriate for the clinical use of the test results.
- Verifies the test procedures performed and establishes the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.
- Enrolls and ensures current participation in an HHS approved proficiency testing program commensurate with the services offered.
- Establishes a quality control program appropriate for the testing performed and establishes the parameters for acceptable levels of analytic performance and ensures that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.
- Resolves technical problems and ensures that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
- Ensures that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.
- Identifies training needs and assures that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
- Should be available to perform and release results of laboratory as necessary.
- Evaluates the competency of all testing personnel and assures that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to:
- Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing.
- Monitoring the recording and reporting of test results.
- Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
- Direct observation of performance of instrument maintenance and function checks.
- Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
- Assessment of problem solving skills; and evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation
Laboratory Manager of a High Complexity Laboratory must possess a current license issued by the State of Florida and must have documentation of one of the following:
- Education and either training or experience to provide technical supervision for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. The director of a laboratory performing high complexity testing may function as the technical supervisor provided he or she meets the qualifications specified in this section.
- Current license issued by the State of Florida
- The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor:
- Masters in Medical Technology, Clinical Laboratory Sciences, Chemical, Physical or Biological Sciences, AND 2 years training/experience in high complexity testing in the respective specialty.
- Bachelors in Medical Technology, Chemical, Physical or Biological Sciences, AND 4 years training/experience in high complexity testing in the respective specialty.
- The Lab Manager must be profiecient and experience in hosting COLA audits.
The job may involve the following:
Very high concentration of work
Strict and tight deadlines
Having to juggle a range of tasks/issues simultaneously
Working in a hazardous environment with high requirement to follow safety procedures
Working outside normal working hours
Needing to respond to client demands
In return you will receive a competitive salary, excellent training and development, as well as an exciting career within a fast paced and dynamic business.