About the Job
The General Supervisor supervises operations of an assigned laboratory section (work center) that conducts sample processing. In particular, the position provides support to Molecular Technicians and Technologists at their location through activities including advanced troubleshooting, the development and execution of training plans, and continuing education. The General Supervisor is responsible for ensuring equipment maintenance and for process improvement initiatives with the primary goal to ensure sample processing is appropriately resourced and scheduled to meet operating goals and result Turn Around Time (TAT). Titles are internal to Foundation Medicine and may not align with Clinical Regulations.
General Supervisors are assigned to a shift and may be assigned to adjust hours or work any day that the lab is operational. This General Supervisor will supervise the pre-lab work centers Extraction and Library Construction. The position's shift will be Monday-Friday, 10:00am-6:30pm.
This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.
• Oversee day to day operations of laboratory section (work center).
• Serve as a technical resource for Technicians and Technologists:
· Provide troubleshooting support.
· Develop and execute training plans and continuing education.
· Ensure approved solutions and reagents are prepared and available for processing.
· Provide on the job training as needed.
· Support competency assessments to ensure laboratory staff are adhering to protocols for their work center.
• Communicate training and competency assessment needs for work center.
• Support the lab management with maintaining and publishing the lab schedule.
• Generate content for lab staff meetings.
• Communicate and escalate issues and delays effectively to necessary personnel.
• Conduct sample tracking and respond to internal client services status inquiries.
• Lead process improvement initiatives.
· Ensure equipment is in functioning order and down time is minimized.
· Collect, maintain and publish operational metrics per work center to ensure sample processing is appropriately resourced and scheduled to meet operating goals and result Turn Around Time (TAT).
• Support the evaluation of new instrumentation, analytical methods and laboratory procedures.
• Perform daily, weekly, monthly and as needed equipment maintenance checks.
• Write, collaborate, revise and review Standard Operating Procedures (SOPs) annually and as needed to adjust for process improvement initiatives and regulatory changes.
• Document and assist with investigations for non-compliance events via Non-Conformance Reports, Corrective Action Preventative Actions, etc.
· Utilize established Quality Management System (QMS) for documenting these events, as needed.
• Provide support for audit activities.
• Support review of records to ensure quality, compliance and adherence to Comprehensive Genomic Profiling (CGP).
• Manage the deployment of temporary deviations as needed.
• Maintain efforts for compliance with laboratory safety protocols.
• Establish a deep understanding of the process in order to troubleshoot assays and instrumentation as needed.
• Lead user testing and requirements gathering to provide feedback for LIMS workflows and software releases.
• As needed:
· Perform highly complex testing according to established SOPs (NGS library prep, hybridization, and sequencing).
· Operate automated 8-span and 96-head liquid handling platforms for sample processing.
· Operate quantification, sizing, and NGS instruments.
· Liaise with other departments for updates on cross functional projects and initiatives.
· Respond to more advanced laboratory operational problem solving, acting as trusted “go to” person for all questions, complex or simple.
· Complete projects fitting of level of expertise and be able to deliver results with minimum guidance.
• Additional project-based work as it pertains to improving the process or providing system requirements in laboratory work center.
• Other duties as assigned.
• Titles are internal to Foundation Medicine and may not align with Clinical Regulations.
• Bachelor’s degree in a biological, chemical, physical, or life science
• 6+ years of relevant lab experience in a CLIA/CAP regulation-adherent lab
• Certifications or licensure that is required by the state or county in which the job is posted
• Familiarity with Laboratory Information Management System (LIMS)
• A high level of experience and knowledge of FMI’s complex NGS laboratory
• Quality management experience and experience with ensuring and maintaining integrity and quality of the lab (sample processing, equipment, QMS)
• Experience writing SOPs and guidelines in the regulated environments referenced above
• Previous experience in managing or leading a process
• Familiarity with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.)
• Proficiency utilizing Microsoft Office Suite, specifically Excel and Power Point
• Knowledge of and experience with Oncology
• Ability to:
· work well under pressure while maintaining a professional demeanor
· prioritize and thoroughly follow up on assigned tasks
· handle multiple tasks at once and work in a fast-paced environment
· adapt to changing procedures, policies and work environment
· work within a highly complex clinical diagnostic laboratory environment within the presence of chemicals and reagents
· work any day and shift that the laboratory is operational
• Understanding of HIPAA and importance of patient data privacy
• Demonstrated integrity and a commitment to values held at FMI: patients, innovation, collaboration, and passion
Internal applicants, please use your FMI email address.