Job Information
Caris Life Sciences Reagent QC Specialist I - Molecular in United States
Position Summary
The Reagent QC Specialist I – Molecular is responsible for maintaining compliance to all applicable regulatory requirements pertaining to the QC process for all incoming reagents which includes initial inspection upon receipt, performing applicable verification testing and assessment, and review of final QC paperwork before passing on to Process Quality for final reagent release into the laboratory.
Job Responsibilities
Maintain compliance to all applicable regulatory requirements (e.g. CLIA, NYS, CAP, FDA, ISO, etc.).
Ensure that Quality Control testing of incoming reagents and materials is performed and documented according to applicable procedures.
Reviews/verifies reagent information (product name, lot number, expiration date, received date, etc.) against information/data captured in the material specification or material receipt record, packing slip, reagent packaging, and material management system.
Alerts applicable departments when discrepancies in the parameters listed above are detected and helps to facilitate corrections of errors as needed.
Responsible for owning and maintaining all reagents pending QC and ensuring all QC testing is done in a timely manner. Continuously follows up on any issues delaying QC to ensure all reagents are tested as promptly as possible.
Performs Molecular Department testing including (but not limited to) Next Generation Sequencing, DNA Methylation analysis (MGMT), DNA/RNA extractions and/or DNA/RNA quantification.
Prioritizes QC for reagents needed urgently as requested by Supply Chain, Receiving, or management.
Takes direction from management and the Material Review Board when QC repeats are needed and tracks all repeat testing within the reagent tracking system.
Maintains all reagent QC storage units (refrigerators, freezers, and room temperature cabinets) to ensure they are clean, organized, and any old reagents are properly disposed. Any problem reagents being held are regularly followed up on until resolution is determined.
Responsible for quarantining any problem reagents found within the laboratory reported by clinical personnel, printing and completing the applicable quarantine sign complete with MRB number when appropriate.
Be available to answer basic questions regarding reagent QC process from clinical personnel or management as needed.
Compile and submit Quality Control documents for review/approval by Departmental partners.
Maintains laboratory equipment and ensures that the equipment is in proper working order and notifies leadership if maintenance and/or repairs are needed.
Demonstrates capability of identifying problems that may adversely affect test performance or reporting of tests results and takes appropriate action.
Communicate material issues to the cross-functional teams, as necessary.
Participate in regular team meetings/ huddles as requested by department management.
Demonstrate an exceptional attention to detail.
Participate in regular team meetings/ huddles as requested by department leadership.
Maintains/completes applicable competency assessments.
Identify opportunities for improvement.
Accepts other duties as assigned.
Required Qualifications
Bachelor’s degree in a scientific field is required (or equivalent work experience).
1+ years’ experience working in a regulated laboratory environment (CLIA, NYS, CAP, FDA, ISO, etc.).
Knowledge of laboratory safety procedures for biohazards and chemicals, as well as quality control procedures and regulations.
Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification.
Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook and general working knowledge of Internet for business use.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening and reference verification.
Preferred Qualifications
Bachelor’s or master’s degree in a scientific discipline.
ASCP or ASQ certifications preferred.
Previous experience with NGS and other molecular processes such as nucleic acid extraction, PCR, quantification, and pyrosequencing.
Ability to manage multiple tasks simultaneously and prioritize as necessary.
Previous Quality Control experience executing reagent or material QC processes.
Previous experience in electronic document control and QMS systems.
Knowledge and adherence to good manufacturing and good documentation practices.
Physical Demands
Must possess ability to sit, stand, and/or work at a computer for long periods of time.
May have exposure to blood-borne pathogens, extreme temperatures, high noise levels, fumes and bio-hazardous material/chemicals including formalin in the lab environment.
May be required to handle blood-borne pathogens and general laboratory reagents.
May be required to lift up to 25 pounds and/or move reagents and materials.
Training
- All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
Other
- This position requires periodic travel and some evenings, weekends and/or holidays.
This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation.
Our laboratory is the heart of what we do. Learn more about our laboratory and the team of histologists who help fulfill our purpose everyday.