The Clinical Laboratory Supervisor is responsible for the supervision of the laboratory personnel and the operations of the Analytical Laboratory during the designated shift. He or she will perform high complexity laboratory testing on patient specimens according to standard operating procedures as needed, interpreting and reporting patient results, and performing quality control and quality assurance procedures while complying with all applicable local, state, and federal laboratory requirements. He or she will be involved with troubleshooting high complexity technical and non-technical problems. He or she will be responsible for managing the validation and ongoing maintenance of new laboratory equipment and will play a major role in the introduction of new test methods into the laboratory.
The Clinical Laboratory Supervisor will participate in the planning and implementation of the assigned corporate and laboratory projects and initiatives. He or she will collaborate with various departments and cross-functional teams to ensure the quality and timeliness with which patient and clinical validation study samples are processed. He or she will communicate timely and effectively with Customer Service and Histology regarding service coverage needs and resolution of issues related to commercial patient samples, adjusting laboratory staffing levels as needed.
The Clinical Laboratory Supervisor will act as a liaison between the Analytical Laboratory and various functional groups including but not limited to Histology, Customer Service, Clinical Laboratory Quality, Quality Control, Service Engineering, Process Engineering, Information Technology, Development Laboratory, Pathology, Materials Management and Facilities groups to report and address immediate issues. He or she must also act as a liaison between staff members, supervisors and the laboratory's senior management team. The Clinical Laboratory Supervisor will assist in the assessment of staffing levels to ensure adequate laboratory capacity and will recruit and hire new employees, reviewing resumes, organizing interview teams, and hiring the selected candidates.
He or she will also be responsible for the ongoing management of their staff, conducting performance reviews and ensuring appropriate work scheduling, training and competency assessment. He or she will assist their staff in the development of their technical and troubleshooting skills and will also ensure that they understand Genomic Health's goals and participate in various project teams to achieve these goals. He or she will facilitate effective teamwork and coordination in patient sample testing and projects, and will collaborate with the laboratory staff to identify and champion operational improvements. He or she will collaborate with Clinical Laboratory Quality team to address issues and concerns promptly and thoroughly.
In order to be successful in this highly complex work environment, the Clinical Laboratory Supervisor must demonstrate leadership, operational management, and organizational skills. He or she must have the ability to facilitate the analysis of complex issues and make sound decisions in a timely manner, the ability to remain professional and composed under pressure, and the ability to respond to difficult issues quickly, fairly, and ethically. This individual must be able to work both independently and collaboratively in a team environment, fostering excellent communication and teamwork within the Analytical Laboratory team and with other functional areas. The Clinical Laboratory Supervisor must be able to utilize various communication channels effectively and proactively communicate team goals and priorities clearly, openly and objectively, and communicate changes, issues, and challenges in all directions of the organization.
Under the supervision of the laboratory senior management team, manage the operations of the Analytical Laboratory including but not limited to ensuring processing systems for patient and study samples are functioning properly, monitoring quality control testing results, monitoring quality assurance performance metrics, planning, validation and implementation of new test procedures, staffing and scheduling, leadership and supervision of Analytical Laboratory personnel, and consistently achieving turnaround time targets.
- Work with the Analytical Laboratory management team and staff on the laboratory's quality control and quality assurance procedures, technical/process troubleshooting and improvement procedures, and staff training and education programs
- Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and immediately communicating these to the appropriate management representatives as necessary for prompt resolution
- Under the directives of the laboratory's senior management team, recruit the required level of staffing and implement workflow improvements to ensure the scalability and consistent quality of laboratory operations
- Collaborate with Histology, Customer Service, Information Technology, Process Engineering, and other functional areas and cross functional teams to address process and workflow issues as assigned
- Participate in the designated laboratory and cross-functional projects such as process improvements, quality improvements, clinical validation studies, and the development and launch of new products
- Write and review standard operating procedures, nonconformance and deviation approval requests, and other documents
- Hold staff meetings; initiate staff development plans and activities to foster team building
- Coach and mentor laboratory staff. Manage staff performance including writing, reviewing and conducting staff performance reviews
- Participate in troubleshooting high complexity technical and non-technical issues as needed
- Assist with the training of new laboratory personnel and training of existing personnel on new procedures as needed
- Ensure consistent compliance with all federal, state, and local regulatory requirements and with all company policies and procedures
- Participate in the inspection preparation activities in the Analytical Laboratory; maintaining consistent, ongoing readiness for inspections and representing Analytical Laboratory during inspections as needed
- Perform laboratory tests, procedures, and analyses according to the laboratory's standard operating procedures as needed
- Review, interpret, and report patient results as needed
- Perform, review and document laboratory quality control procedures as needed
- Operate, maintain, and troubleshoot laboratory equipment as needed
- Perform other duties as assigned
- Current California Clinical Laboratory Scientist license
- B.S., M.S., or Ph.D. in a relevant biological or clinical science discipline
- Related clinical laboratory experience: 6+ years for candidates with a B.S. degree, 4+ years for candidates with an M.S. degree, or 2+ years for candidates with a Ph.D. degree.
- Working knowledge of local, state, and federal regulatory requirements for the Clinical Laboratory regulations
- Excellent attention to detail, great organizational skills and a strong desire to provide superb service to internal and external customers
- Experience with word processing and spreadsheet applications
- Experience with using Laboratory Information Management Systems (LIMS)
- Experience with one or more standard molecular biology techniques such as nucleic acid isolation, RNA/DNA quantification, PCR and RT-PCR, DNA sequencing is desirable
- Ability to quickly adopt and apply new methods and technologies
- Ability to quickly and calmly adapt and respond to and help others through changes in priorities, timelines and deliverables
- Desire to mentor, coach and develop employees
- Ability to analyze and solve moderately complex issues that impact laboratory processes
- Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed
- Ability to integrate and apply feedback in a professional manner
- Ability to prioritize and drive to results with a high emphasis on quality
- Ability to work as part of a team
- Management experiences with proven track records of implementing changes, scaling operations for growth, staff development, and building successful teams
- Ability to analyze and solve highly complex technical and non-technical problems
- Experience with high volume laboratory operations
- Experience in applying project management skills to leadership of operational expansion and process improvement projects
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Standing or sitting for long periods of time may be necessary
- Some lifting (greater than 25 pounds) may be necessary
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation
- Repetitive manual pipetting may be necessary
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