The Senior Laboratory Education Specialist will develop and maintain a detailed and comprehensive knowledge of all laboratory workflows within Genomic Health's Analytical Laboratory, and will have primary accountability for overseeing the Clinical Laborator Scientist (CLS) and Laboratory Assistant (LA) training, competency assessment and continuing education programs, including evaluation of the current program, developing and implementing necessary improvements to maintain effectiveness, identifying initiatives for future needs, and ensuring that documentation meets regulatory requirements and complies with company policies. The role includes leading a training team who will assist with the hands-on training and working one on one with new hires to provide a comprehensive, consistent and effective training program. Providing guidance and mentorship to the trainers on the fundamentals of teaching and learning styles will be a vital responsibility. The coordinator will also be involved in managing the CLS/CGMBS student internship program and in-house continuing education program to provide learning opportunities to the staff.
The Senior Laboratory Education Specialist will participate in performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The processes include, but not limited to nucleic acid isolations, RNA/DNA quantification, RT-PCR, other molecular techniques, LIMS functionality, and the spectrum of interactions between Analytical Laboratory and other functional areas. The Senior Laboratory Education Specialist will participate in patient testing on a regular basis approximately 50% of the time to maintain technical skills and knowledge.
The education role and the high complexity nature of the laboratory work are cross-functional, and both require excellent verbal and written communication skills and collaboration with colleagues in Histology, Customer Service, Pathology, Clinical Laboratory Quality Assurance, Health and Safety, Service and Process Engineering, as well as members within the Analytical Laboratory. In addition, a successful coordinator will be self-motivated and requires attention to detail, excellent follow-through, adaptability to change, the ability to manage projects and time effectively, the ability to proactively seek input and integrate feedback for improvements and to be flexible with tasks and schedules, and the ability to work independently in a team environment. With the regulatory compliance playing an ever-increasing role at Genomic Health, the coordinator must have a strong understanding of current regulations to ensure training and educational programs are in compliance. The Senior Laboratory Education Specialist will consistently demonstrate Genomic Health core values.
- Evaluate current training program, develop and implement improvements and identify future needs.
- Evaluate current continuing education strategy, develop and implement improvements and identify future needs.
- Review and evaluate training program for compliance with company policies and regulatory bodies, e.g. CLIA, CAP and NY State, ISO 15189, etc.
- Lead a training team to assist with hands-on training and to help develop a comprehensive and effective program.
- Maintain and develop written procedures to document all aspects of the training program.
- Maintain an inventory of training samples and other materials required for training of all process steps.
- Accountable for maintaining and updating employee personnel training and continuing education files in the Analytical laboratory for internal and external inspections.
- Accountable for maintaining and updating intern training documents in the Analytical Laboratory for training programs we are affiliated with.
- Prioritize a positive work environment by investing time in building relationships and trust with all stakeholders and exhibit a dedication to team work above and beyond scheduled daily work.
- Conduct orientation and supervise training for new employees, contractors and interns.
- Monitor and review progress of trainees and provide training documents and status reports to Supervisors and other stakeholders.
- Monitor and review staff competency and ensure that documentation is complete and up-to-date.
- Perform laboratory tests, procedures and analyses according to the laboratory's standard operating procedures.
- Perform, review and document laboratory quality control procedures.
- Operate, maintain and troubleshoot laboratory equipment.
- Prepare reagents required for laboratory testing.
- Review, interpret and report patient results.
- Identify and troubleshoot problems that adversely affect test performance.
- Supervise the work of unlicensed laboratory personnel.
- Demonstrate the ability to train laboratory personnel on current and new procedures.
- Maintain sufficient inventory of laboratory supplies for daily operations.
- Lead and/or participate in testing and validation of new laboratory equipment and procedures as needed.
- Participate in quality assurance activities.
- Must communicate effectively with coworkers and non-laboratory personnel.
- In the absence of supervisors, able to address issues with non-laboratory personnel, and relay information back to supervisors and staff.
- Provide assistance to the Laboratory Supervisors including but not limited to
- Writing and reviewing of procedures, documents and forms.
- Coaching Clinical Laboratory Scientists and Laboratory Assistants by providing guidance and constructive feedback.
- Assistance in developing the troubleshooting and decision-making skills of the Clinical Laboratory Scientists and Laboratory Assistants.
- 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 resolution
- Perform other duties as assigned.
- Must possess a valid California CLS license.
- At least five years of clinical laboratory experience as a Clinical Laboratory Scientist, CGMBS or equivalent in a high complexity molecular laboratory.
- Possess intermediate to advanced working knowledge of local, state and federal laboratory regulations.
- Demonstrated aptitude and enthusiasm relevant to teaching and continuing education.
- Demonstrated professionalism and leadership skills.
- Experience with using Laboratory Information Management System (LIMS), word processing and spreadsheet software.
- Strong technical skills and job industry knowledge.
- Intermediate to advanced level project management skills.
- Ability to prioritize and drive to results with a high emphasis on quality.
- Ability to analyze and problem solve issues that impact trainees' performance or learning experiences.
- Ability to analyze and problem solve complex issues that impact test performance.
- Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
- Ability to effectively communicate technical and non-technical information to technical and non-technical audiences.
- Ability to provide and receive constructive feedback.
- Ability to integrate and apply feedback in a professional manner.
- Ability to manage daily test processing needs along with project needs in a high quality, efficient and effective manner.
- Ability to work as part of a team.
- Ability to perform repetitive tasks.
- Experience with leading and mentoring a training team.
- Experience with developing and sustaining training and competency assessment programs.
- Experience with high volume laboratory operations.
- Experience with laboratory automation and robotic equipment.