PCR Supervisor (PGx Testing)

Description

JOB OVERVIEW

The PCR Supervisor is responsible for leading the team of PCR Specialists and overseeing the daily operations in the Microbiology department, including testing patient specimens for pharmacogenetics (PGx) test orders using a MALDI-TOF instrument platform. In addition, this person will ensure patient lab reports are accurate and completed on time, be accountable for proper documentation and compliance with regulations, oversee required studies and validations, evaluate opportunities for process improvement, and participate in developing new processes for instrumentation and testing methods, as needed. 

ESSENTIAL FUNCTIONS

• Oversee the daily operations of the Microbiology department
• Ensure adherence to BSL-2 safety standards within the Microbiology department
• Ensure adherence to CAP, CLIA, and NYS standards within the Microbiology department
• Ensure adherence to Ethos Standard Operating Procedures (SOPs) and Policies
• Ensure patient specimens are tested accurately and lab reports are released on time, utilizing data reports
• Oversee instrument and equipment maintenance, scheduling with vendors as needed
• Maintain appropriate records of certifications, repairs, and maintenance for lab instruments and equipment 
• Provide direct leadership for the team of PCR Specialists
• Hold weekly department meetings to share updates with the team
• Establish and monitor Key Performance Indicators (KPIs) for the PCR Specialists
• Hold monthly KPI meetings for ongoing coaching and feedback
• Track and maintain data and instrument performance indicators on a daily, weekly, monthly, quarterly, and annual basis
• Establish and monitor department metrics for turnaround time, accuracy, throughput, expenses, etc.
• Participate in interdepartmental meetings to share department metrics, challenges, new processes, etc.
• Collaborate and communicate with other department leaders
• Review and/or create SOPs and controlled documents within the Microbiology department as needed
• Develop new and improve existing PCR processes as needed
• Take steps to increase efficiency and productivity with instrument processes, minimizing downtime while maintaining optimum conditions
• Identify, troubleshoot, and analyze issues or trends related to instrument operation, instrument repair, calibrations, quality controls, workflow, patient data, etc.
• Document incidents and accidents on the appropriate forms and perform remedial training, if required, to prevent further incidents/accidents
• Escalate issues to the Laboratory Manager, Laboratory Director, Quality Manager, or VP of Operations as needed
• Interview, hire, onboard, and train new employees
• Complete employee competency assessments initially, after first 6 months, and annually
• Participate in developing new processes for instrumentation and testing methods as needed
• Become fully trained and competent in PCR Specialist responsibilities to support the team with daily functions during periods of high volume or to cover absences
• Exemplify and encourage positive interactions within the lab to inspire collaboration and teamwork
• Other duties as assigned 

Requirements

PROFESSIONAL REQUIREMENTS

• Deep knowledge of pharmacogenetics (PGx) testing
• Deep knowledge of PCR processes, instrumentation, and workflows
• Proficient in operating, maintaining, and troubleshooting MALDI-TOF instruments, extraction equipment, liquid handlers, thermal cyclers, and other instruments/equipment
• Demonstrated experience creating, revising, and operating from SOPs
• Ability to lead by example
• Ability to model and foster in others time management, conscientiousness, dedication, and accountability
• Ability to listen, learn, and promote accountability and responsibility related to all processes
• Ability to maintain the highest level of confidentiality and adherence to HIPAA regulations
• Must be able and willing to follow established protocols employing acceptable standards of analysis and the use of judgment in searching for solutions or new applications within one’s own experience
• Must be able and willing to wear personal protective equipment (PPE) when required
• Proficient with Microsoft Office applications

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor of Science (or higher) in Chemistry, Pharmacology, Biology, Medical or Clinical Laboratory Science, Medical Technology, or similar analytical science field with minimum of 4 years of relevant experience
• Per CAP standards, years of experience must include the following: At least 2 years in high-complexity testing; At least 1 year in molecular pathology methods
• Must have experience performing pharmacogenetics (PGx) testing
• Must have experience supervising a laboratory department that conducts pharmacogenetics (PGx) testing
• Preference for candidates with experience operating MALDI-TOF instruments
• Preference for candidates with experience developing or optimizing PCR processes
• Preference for candidates with experience in a high-throughput production laboratory
• Preference for candidates with experience with CLIA, COLA, CAP, and/or NYS standards

KNOWLEDGE, SKILLS AND ABILITIES

• Critical thinking and problem solving, with a high level of attention to detail
• Must have leadership qualities and be able to supervise employees
• Ability to communicate effectively, orally and in writing
• Excellent time management, scheduling, documentation, and organizational skills
• Must be flexible, innovative, and self-motivated
• Must be able to motivate, coach, and mentor employees for highest level of performance
• Must be able to delegate and accomplish goals through others
• Must be experienced with laboratory software

PHYSICAL REQUIREMENTS

• Work is performed in a laboratory environment and exposes the incumbent to normal laboratory hazards and chemicals, including biohazard materials
• Work in varying degrees of temperature (heated or air conditioned)
• Position requires sitting, walking, reaching, bending, stooping, and handling objects with hands and/or fingers, talking and/or hearing, and seeing

DIRECT REPORTS

• PCR Specialist(s)