Lab Manager

Position Overview:

The Lab Manager is responsible for the overall management of operations within the laboratory environment, including the development and implementation of laboratory procedures, coordination of testing activities, oversight and maintenance of material resources, and ensuring the safety of laboratory operations. The Lab  Manager is also responsible for maintaining quality assurance programs in accordance with CLIA, CAP and state regulations and coordinating the proper logistical functions (both pre- and post- analytical) necessary to maintain business operations.

Required Education, Skills and Experience:

  • Bachelor’s Degree or equivalent with experience in clinical diagnostics
  • A broad range of management skills with particular emphasis on leadership, motivation, communication, and planning
  • Ability to foster and maintain internal and external business partnerships to achieve organizational goals
  • Must have proficient computer skills including a working knowledge of Microsoft Office products
  • In-depth knowledge of complex laboratory techniques, laboratory safety and quality assurance to support ongoing and future projects
  • In-depth knowledge of CLIA, CAP and state laboratory regulations including federal and state regulations that govern Laboratory Developed Tests.

Essential Functions/Responsibilities (other duties may be assigned):

  • Activily coaches, mentors and develops employees; collaborates with supervisors to provide timely performance evaluations and manage disciplinary action as required
  • Interviews and hires new employees in the lab
  • Guides laboratory infrastructure development including writing test procedures, SOP’s, validation and investigation reports
  • Continually improves laboratory performance by investigating alternatives, preparing proposals, developing and performing parallel testing, and monitoring progress
  • Supports new product development initiatives
  • Coordinates the forecast and procurement of all test materials and lab supplies
  • Maintains medical laboratory supplies inventory by checking stock to determine inventory levels, anticipating needed supplies, placing and expediting orders for supplies, and verifying receipt of supplies
  • Implements and maintains quality assurance programs to ensure:

o   Compliance with regulatory guidelines

o   Conformity of all lab tests under CAP/CLIA guidelines

o   Adherence to latest standards and guidelines

o   Chemical Hygiene and Safety plans are established and followed

  • Manages quality assurance programs including but not limited to Internal and External audits, Corrective and Preventive Action, Document Management, Proficiency Testing, Calibration and Preventive Maintenance
  • Communicates with CLIA, CAP and other regulators as required and participates as lead during external audits
  • Ensures that relevant laboratory licenses are maintained and that the laboratory is compliant with such licenses
  • Maintains quality metrics in accordance to company’s quality assurance program, performing proficiency surveys, reviewing quality control and quality assurance programs, making adjustments in policy and procedures, generating reports, and maintaining records
  • Manages Pre- and Post-Analytical processes to ensure accurate and prompt completion of business goals
  • Builds and maintains positive working relationships with vendors and clients
  • Coordinates, implements, and maintains strategic partnerships, internally and externally, to meet operational business needs
  • Maintains medical laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair
  • Maintains medical laboratory productivity by monitoring workload of functional areas, identifying peak and slack periods and making operational or staffing adjustments as needed
  • Maintains medical laboratory information system by identifying information needs and problems, recommending improvements, establishing priorities, testing, writing user manuals, training employees, and maintaining security and confidentiality
  • Completes operational requirements by scheduling and assigning employees; following up on work results
  • Maintains laboratory staff results by counseling and disciplining employees, planning, monitoring, and appraising job results
  • Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies
  • Complies with state and professional continuing education licensure requirements by providing in-service programs; monitoring outcomes, etc.