Caris Life Sciences · 10 hours ago
Reagent Quality Control Specialist I - Molecular Operations
Caris Life Sciences is transforming cancer care and changing lives through precision medicine. The Reagent QC Specialist I is responsible for maintaining compliance with regulatory requirements and performing quality control testing on incoming reagents to ensure they meet necessary standards.
Artificial Intelligence (AI)BiopharmaBiotechnologyHealth CareLife Science
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
Qualification
Required
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
Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook and general working knowledge of Internet for business use
Preferred
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
Company
Caris Life Sciences
Caris Life Sciences develops molecular profiling and AI-driven technologies to support precision medicine in oncology.
Funding
Current Stage
Public CompanyTotal Funding
$1.86BKey Investors
BraidwellOrbiMedSixth Street
2025-06-18IPO
2025-04-07Private Equity· $168M
2023-01-19Debt Financing· $400M
Recent News
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2026-01-17
2026-01-14
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