Clinical Laboratory Supervisor
Under the direction of Director of Lab Operations, the lab supervisor would provide day-to-day supervision of testing schedule and reporting of test results. The clinical Laboratory Supervisor is also responsible for validating and implementing new developed assays according to clinical laboratory protocol. He/she would maintain clinical laboratory quality assurance protocol in compliance to CLIA and CAP regulation and accreditation requirements. In addition, the lab supervisor will assist in establishing new client’s facility setup and continue support to clinical trial projects within the company. The position is best suited for a candidate who can efficiently work in a diverse laboratory environment, goal-oriented laboratory services setting.
- Strong technical background on chemistry, immunophenotyping and molecular assays using various methods including flow cytometry, ELISA, qPCR in clinical laboratory settings.
- Experience on validate and implement laboratory developed clinical test
- Establish and maintain clinical laboratory quality assurance protocol
- Ensure proper performance of laboratory procedures and quality assurance standards
- Documentation of QA process in relate to all aspects within laboratory
- Assessment of staff performance and ensure high quality test result with satisfaction turnaround time
- Provide troubleshooting of laboratory instrumentation and methodologies concerns
- Interact with vendors and manufacturers regarding technical assistance.
- Monitor and maintain acceptable levels of analytic performance
- Provide training and orientation for both licensed and unlicensed lab employees
- Resolve problems and ensure remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
- Ensures all procedures and practices of phlebotomy services compliance to blood draw requirements and regulations
- Coordinates, setup and continue monitor for offsite specimen collection and training at clients’ facilities
- Maintain satisfaction services to clients in relate to test results and promptly attends to clients concerns and questions.
- Manage the logistic and pickup schedules for specimen shipping and transportations
- Identify training needs and assures all lab personnel receive regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
- Evaluate the competency of all testing personnel and assures the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.
- Review worksheets, test results, quality control records, proficiency testing results, and preventive maintenance records.
- Monitor performance of instrument maintenance and function checks.
- Assess test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
- Evaluate and document the performance of individuals responsible for high complexity testing at pre-determined interval.
- Create, reviews and revises Standard Operating Procedures, with periodic updates, to ensure Lab Director review and approval for all new and/or revised procedures.
- Ensure that QC is within appropriate limits and that all test results are accurate, performing weekly QC reviews as required.
- Oversee the inventory and ordering of supplies process.
- Maintain the performance and recording of Proficiency Testing.
- Manage schedules and maintain complete coverage of all shifts in the laboratory.
- Perform assessment of the operation of all instruments in areas of responsibility and assign maintenance procedures or repairs as needed.
- Ensure all lab equipment is always calibrated and functioning effectively.
- Ensure that the records are organized, neat and readily retrievable.
- Ensure that all specimens are organized and readily retrievable.
- Meet target dates and due dates for completion of tasks.
- Ensure that the lab is organized, neat and clean.
- Provide back up to any technical or clerical position as needed.
- Thorough understanding and experience in managing CLIA and CAP laboratory in compliance to regulatory and accreditation requirements
- Review, implement and monitor lab protocols to ensure continue laboratory operation of high-quality standards
- Maintain a safe laboratory environment in compliance with OSHA and CLIA regulations
- Assign priority and CLS functions in the laboratory, performing all analytical procedures, to include specifically:
- Prepare all solutions, such as, calibrators, etc. either by automation or manual pipetting techniques.
- Calibrations and Quality Controls
- Specimen preparations that require dilutions and pipetting techniques
- Loading samples onto all high complexity testing processes
- Reviewing, approving and releasing all QC and patient results
- Troubleshoots problems (client, instrument, computer) as needed.
- Perform any other duties as assigned by the Director of Laboratory Operations
- Excellent verbal and written communication skills.
- Demonstrate critical analysis and complex problem-solving skills.
- Demonstrate ability to manage highly confidential and proprietary information.
- Excellent organizational skills
- Proficient in computer skills that include spreadsheets and word processing software, and Microsoft Office required.
- Ability to perform complex lab tasks and maintain patient confidentiality.
- Complies with applicable legal requirements, standards, and procedures including, but not limited to, those within the Compliance Process, Code of Conduct, HIPAA, State, CAP and CLIA.
- Provides leadership and support for the Compliance process within management area.
- Ensures timely and accurate reporting and responses to compliance-related issues and assists with implementation of corrective action plans related to such issues.
- Reports concerns and suspected incidences of non-compliance to Lab Director.
- Provides open lines of communication regarding compliance issues within management areas and ensure that retaliation against staff who report suspected incidences of non-compliance does not occur.
- Participates in monitoring and auditing activities and investigations, and implementing quality improvement processes, as required.
NOTE: The above statements are intended to describe the general nature and level of work performed by an employee in this position. They are not intended to be construed as an exhaustive list of all tasks and responsibilities required. All employees may be required to perform duties outside of their normal responsibilities from time-to-time, as needed.
Job Qualifications & Skills
Education: BS / BA degree in Science required.
- Experience: Minimum eight (8) years of clinical laboratory required.
- License/Certification: Current California State License for Clinical Laboratory Scientist required.
- ASCP certification from the American Society for Clinical Pathology preferred.
- Proficient in Microsoft Word and Excel
- Excellent critical thinking and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Excellent organizational skills
All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.