Cleveland Diagnostics has developed a breakthrough technology with high sensitivity and specificity for prostate cancer and is now establishing a CLIA Laboratory to launch the test and continue the development of future tests in the field of cancer.
We currently have an immediate opening for a General Supervisor in our CLIA Laboratory. This is an excellent opportunity to be actively involved in the design, start-up and implementation of the lab including workflow, procedures, and policies. In this dynamic role you will also be engaged in the company's R&D program.
Job Description: The General Supervisor/Technical Coordinator will direct the administrative and technical operations of the CLIA laboratory at Cleveland Diagnostics. The General Supervisor will be responsible technically for the procedures performed in the CLIA Laboratory. In addition, the General Supervisor will support the Cleveland Diagnostics R&D team by performing analytical procedures including testing of specimens and/or blood products supporting the development and commercialization of pipeline products.
- Performs moderate and high complexity analytical processes without direct supervision. Includes operation of immunoassay analyzers, clinical chemistry analyzers, and standard wet chemistry equipment such as pH meters, spectrophotometers, automated liquid handlers, etc.
- Develops and updates to current standard complete technical procedure manuals per CAP and CLIA Guidelines.
- Completes all tasks/assignments delegated by the Medical Director.
- Develops and implements contingency plans to avert possible interruptions in services due to technical or mechanical issues.
- Responsible for the accuracy of all tests performed within the CLIA Lab. Ensures quality of testing through review of quality control data and test result. Responsible for the accuracy of reference ranges within the lab.
- Assures competency of all technical staff utilizing the CLIA defined competency elements.
- Ensures technical proficiency of staff and self through the participation of internal competencies (technical and computer) and external proficiency testing programs.
- Assures testing is in accordance with production schedule and that variances from schedule are identified, resolved and communicated to the Laboratory Director in a timely manner.
- Downtime exceptions (instrumentation) are communicated to appropriate staff within a timely manner.
- Demonstrates competency in statistical analysis, quality control review and instrument linearity/correlations.
- Communicates with physicians and clinicians on patient care issues.
- Responsible to communicate (inform and get input from) procedural issues with the Medical Director.
- Implements the standard of CAP, CLIA and other pertinent accrediting agencies.
- Assist in the implementation of and participates in an effective Laboratory Performance Improvement Program.
- Promotes participation among technical and support staff in Performance Improvement activities. Empowers Laboratory staff to assist with problem resolution.
- Adheres to the company’s quality control policies; documents all quality control activities including calibrations and maintenance performed. May develop and implement additional quality control policies and documents to support product development.
- Maintains instruments and equipment in accordance with manufacturer’s specifications.
- Maintains clear and legible records.
- Plans, organizes, performs, and monitors daily project activities.
- Responsible for materials management including effective utilization of supplies and monitoring of inventory to maintain suitable stock.
- BA/BS in Chemical, biological or clinical laboratory science.
- MT (ASCP) or MLS (ASCP) certification.
- Three years of experience working in clinical or CLIA lab environment with 1-year management experience.
- Experience operating and maintaining Roche cobas e411 and/or 6000 clinical chemistry and immunoassay analyzers preferred.
- Experience working with and/or developing ELISA assay preferred.
- Understands and complies with good laboratory practices, including safety, HIPPA, confidentiality and regulatory requirements.
- Requires critical thinking skills and decisive judgement skills.
- Must be a self-starter with high motivation level and eagerness to learn.
- Detail oriented.
- Excellent aptitude for troubleshooting laboratory equipment.
- Effective interpersonal, organizational and communication skills required.
- Excellent computer skills with proven proficiency in Microsoft Office products including Word and Excel.
Work involves a fast-paced laboratory environment with a moderate amount of walking, standing, and/or sitting with occasional light lifting. Fine motor skills and manual dexterity to handle specimens and lab equipment. Work is performed in general laboratory environment, possible exposure to bloodborne pathogens and hazardous chemicals requiring the use of personal protective equipment.
We offer an excellent benefits package which includes medical, dental, vision, life, short term disability and a matching retirement savings program.
Job Type: Full-time
- working in clinical or CLIA Lab: 3 years (Required)
- MT (ASP) or MLS (ASCP) (Required)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Signing bonus
- Paid time off
- Flexible schedule