PCR Specialist

Description:

JOB OVERVIEW

The PCR Specialist is responsible for specimen preparation, instrument operation, specimen processing, data analysis, and certifying results for a standard PCR workflow, including testing for respiratory pathogens, infectious diseases, and/or pharmacogenetics (PGx). In addition, this person will ensure laboratory instruments and equipment are maintained, laboratory inventory is stocked, and proper documentation is completed according to Standard Operating Procedures (SOPs).

ESSENTIAL FUNCTIONS

• Complete training and competency for patient specimen testing for respiratory pathogens, infectious diseases, and pharmacogenetics (PGx).
• Learn the purpose of each step in the testing process to better understand the overall process and become effective at troubleshooting.
• Ensure adherence to BSL-2 safety standards, Good Laboratory Practices (GLP), Standard Operating Procedures (SOPs), company policies, and regulatory requirements for CLIA, CAP, and NYS.
• Perform specimen preparation for a standard PCR workflow following established SOPs.
• Pipette specimens, standards, and reagents in a careful and accurate manner using single-channel and multi-channel pipettes, as well as 96-well plates and 384-well plates.
• Operate standard PCR equipment and instruments, including but not limited to: automated liquid handlers, automated extraction systems, thermal cyclers, ABI 7500 Fast instruments, QuantStudio 7 Flex instruments, and Agena MassARRAY MALDI-TOF instruments.
• Review patient specimen data from multiple instruments, ensuring quality metrics are within specifications.
• Review, certify, and release patient lab reports when all ordered testing is final.
• Perform required daily, weekly, monthly, and as needed maintenance for PCR equipment and instruments.
• Document steps performed in the process to track completion times, temperatures, and instruments used per CLIA and CAP regulations; notify appropriate personnel of any issues throughout the testing process.
• Stock and refill reagents, inventory, and supplies for lab operations throughout the day.
• Maintain appropriate inventory of reagents, parts, and supplies needed for continuous operation of all PCR equipment and instruments; notify the PCR Supervisor when reagents, parts, or supplies should be ordered.
• Maintain appropriate certifications and records for PCR equipment, including but not limited to: centrifuges, manual and automatic pipettes, thermal cyclers, refrigerators, freezers.
• Store patient specimens for the appropriate retention period at the required temperature.
• Dispose of patient specimens that have reached their retention date in appropriate biohazard containers.
• Communicate effectively with other departments about issues regarding specimen processing.
• Identify and troubleshoot specimen preparation or instrument issues, as needed, and work with the PCR Supervisor, Production Manager, and/or Quality Manager to identify root causes and corrective actions.
• Take steps to increase efficiency and productivity with instrument processes, minimizing downtime while maintaining optimum conditions and turnaround time.
• Assist in training of other team members and any special projects (AMR studies, validations, verifications, proficiency testing, CAP inspections, etc.) that arise throughout the year.
• Encourage positive communication and interactions within the lab to increase collaboration and teamwork.
• Meet established Key Performance Indicators (KPIs) for turnaround time, accuracy, and overall quality.
• Participate in meetings and a wide variety of special projects, as needed.
• Complete general lab tasks as needed.
• Other duties as assigned.

Requirements:

PROFESSIONAL REQUIREMENTS

• Deep knowledge of PCR processes, instrumentation, and workflows
• Proficient in use of single-channel and multi-channel pipettes
• Proficient in operating laboratory instruments, equipment, and computers with scientific software
• Ability to perform work following established SOPs, ensuring the highest quality standards are maintained
• Ability to maintain the highest level of confidentiality and adherence to HIPAA regulations
• Must be able to meet established production benchmarks in terms of quality, volume, timeliness, and adherence to established policies
• Ability to effectively troubleshoot process/instrument issues using critical, strategic, and analytical thinking
• Ability to listen, learn, and promote accountability and responsibility related to all laboratory processes
• Must be able and willing to wear personal protective equipment (PPE) when required
• Proficient with Microsoft Office applications
• Ability to model time management, conscientiousness, dedication, and accountability
• Regular and prompt attendance

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor of Science in Life Science, Pharmacology, Toxicology, Biology, Physics, Chemistry, or similar analytical science field with minimum of 2 years of relevant experience; OR Master of Science with minimum of 1 year of relevant experience
• Must have experience working a laboratory that conducts PCR testing
• Preference for candidates with experience in a high-throughput production laboratory
• Preference for candidates with familiarity with pipetting, extractions, and use of 96-well plates
• Preference for candidates with experience working with bodily fluids/specimens, such as urine, nasal swabs, cheek swabs, and genital swabs
• 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
• Ability to communicate effectively, orally and in writing
• Excellent time management, scheduling, documentation, and organizational skills
• Skill in data entry and review with minimal errors
• Ability to function in a team environment and promote collaboration
• Must be flexible, innovative, and self-motivated
• Must be experienced with laboratory software
• Must be able to work under limited supervision where the work assignments are subject to established procedures, techniques, and well-defined policies

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

• None