Confirmation Scientist II

Mako Medical
Raleigh, NC Full Time
POSTED ON 12/1/2023 CLOSED ON 12/12/2023

What are the responsibilities and job description for the Confirmation Scientist II position at Mako Medical?

Job purpose

  • Able to fulfil the role of General Supervisor as defined by College of American Pathologists (CAP) by being responsible for the day-to-day supervision or oversight of the laboratory operation(s) and personnel performing testing and reporting test results.
  • In the absence of the Director, Manager, and Technical Supervisor, the General Supervisor must be responsible for the proper performance of all laboratory procedures and reporting of test results.
  • Supports the Technical Supervisor in optimizing laboratory workflow by providing process feedback to Technical Supervisors, Manager, and/or Director, implementing changes, and assisting in SOP updates as necessary.
  • Assists Technical Supervisor in monitoring test performance and ensures remedial actions are taken when test systems deviate from the laboratory's established performance specifications.
  • Assist in the orientation, training, and competency assessment of other laboratory staff or personnel to perform testing or operate instrumentation as requested by the Technical Supervisor.
  • Provides resolution to a wide variety of technical problems in accordance with established policies and procedures. Duties and responsibilities
  • Performs planning for setting goals and developing and allocating resources appropriate to the clinical laboratory environment.
  • Provides educational programs for the laboratory staff and participates in educational programs of the institution.
  • Provides daily supervision of high complexity test performance by qualified testing personnel.
  • Monitors test analyses and specimen examinations to ensure that acceptable levels of analytical performance are maintained.
  • Serves as a key operator responsible for operating, troubleshooting, and maintaining LCMS instrumentation, Hamilton liquid handling system, and associated reagents, consumables, work processes and sample analysis.
  • Performs LCMS and Hamilton instrumentation preventative maintenance and repairs any issues not covered under service contracts.
  • Maintain and monitor reagent integrity, order materials as necessary, make and ensure quality of working stock solutions using SOPs.
  • Independently participate in CAP Proficiency Testing (PT).
  • Organizes, reviews, reports, and archives laboratory data in accordance with approved SOPs, quality control guidelines, or supervisory guidance.
  • Reviews and certifies MS data for reporting in accordance with approved SOPs, and quality control guidelines. Seek corrective action for patient samples not meeting these criteria during data review.
  • Ensure that work requirements are completed in a timely, organized manner to very high standards and in compliance with protocols, SOPs, and CAP/CLIA regulations or guidelines.
  • Ensure that facilities, equipment, supplies, and reagents are maintained and used in the same manner and administered in accordance with applicable safety, occupational health, and environmental protection guidelines, policies, and regulations.
  • Maintain up-to-date knowledge of the field of toxicology and those techniques and instrumentation management and reporting of clinical data.
  •  Responsible for reading and understanding of all required SOPs and assigned continuing education courses.
  • Additionally, the Director or Manager may delegate in writing to the General Supervisor the responsibility of:
    - Assuring that all remedial actions are taken, and investigation are sufficiently completed whenever test systems deviate from the laboratory’s established performance specifications;
    - Providing orientation to all testing personnel.
  • Other duties as assigned.

Minimum Qualifications

  • Bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology
  • At least one year of training and/or experience in high complexity CLIA certified toxicology laboratory.
  • Process-driven self-starter.
  • Knowledgeable of required regulations and compliance.
  • Ability to work with accuracy and speed in a team-oriented environment.
  • Superior written and verbal communication skills and basic leadership skills.
  • Ability to manage detailed information with minimal errors and complete accuracy.
  • Prior experience with AB Sciex 4500/5500/6500 or equivalent preferred.
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