Supervisor, Reagent Quality Control, Molecular Operations
Caris Life Sciences
August 19, 2026
On-site
Phoenix, AZ
Operations
Position Summary:
The Supervisor - Reagent QC Molecular Operations oversees daily operations of the molecular reagent quality control (QC) function, including supervising QC testing of incoming reagents/materials, ensuring regulatory compliance (CLIA, CAP, NYS, FDA, ISO, etc.), managing reagent release, providing technical guidance, supporting process improvements, and ensuring the accuracy, timeliness, and integrity of QC activities.
Job Responsibilities:
- Supervise daily QC operations for molecular reagents/materials per approved SOPs and regulatory standards.
- Ensure QC testing of incoming reagents/materials is performed and documented.
- Provide technical leadership to QC staff performing molecular verification testing (e.g., NGS, DNA/RNA extraction and quantification, other molecular assays).
- Ensure compliance with laboratory quality and safety regulations (CLIA, CAP, NYS, FDA, ISO).
- Monitor/prioritize workload to ensure timely testing and release of materials for clinical operations.
- Troubleshoot and conduct root-cause investigations for QC nonconformances/deviations/test failures; initiate/participate in CAPA.
- Train and mentor QC personnel; ensure competency and adherence to SOPs.
- Support Change Control and update related documentation (SOPs, forms, QC records).
- Maintain equipment/instrument readiness (calibration, preventive maintenance, documentation).
- Review/approve QC records and test data per Good Documentation Practices (GDP).
- Support audits/inspections with QC documentation and readiness.
- Track/report reagent QC KPIs.
- Identify and implement process improvements; promote a quality/safety/continuous improvement culture.
- Perform other duties as assigned.
Required Qualifications:
- Bachelor’s degree in a scientific field.
- 5+ years’ experience in a regulated laboratory environment (CLIA, CAP, NYS, FDA, or ISO), including 2+ years performing/overseeing QC or testing.
- Supervisory experience in a laboratory.
- Knowledge of molecular techniques (NGS, PCR, nucleic acid extraction, quantification, related assays).
- Working knowledge of quality systems and reagent QC processes.
- Proficiency in Microsoft Office; experience with LIMS/QMS.
Preferred Qualifications:
- Master’s degree.
- ASCP (MB) or ASQ certification.
- Familiarity with GMP/GLP and GDP.
Other:
- Periodic travel and some evenings/weekends/holidays.
Conditions of Employment:
- Complete pre-employment screening (criminal background check, drug screening, credit check for certain positions, and reference verification).
The Supervisor - Reagent QC Molecular Operations oversees daily operations of the molecular reagent quality control (QC) function, including supervising QC testing of incoming reagents/materials, ensuring regulatory compliance (CLIA, CAP, NYS, FDA, ISO, etc.), managing reagent release, providing technical guidance, supporting process improvements, and ensuring the accuracy, timeliness, and integrity of QC activities.
Job Responsibilities:
- Supervise daily QC operations for molecular reagents/materials per approved SOPs and regulatory standards.
- Ensure QC testing of incoming reagents/materials is performed and documented.
- Provide technical leadership to QC staff performing molecular verification testing (e.g., NGS, DNA/RNA extraction and quantification, other molecular assays).
- Ensure compliance with laboratory quality and safety regulations (CLIA, CAP, NYS, FDA, ISO).
- Monitor/prioritize workload to ensure timely testing and release of materials for clinical operations.
- Troubleshoot and conduct root-cause investigations for QC nonconformances/deviations/test failures; initiate/participate in CAPA.
- Train and mentor QC personnel; ensure competency and adherence to SOPs.
- Support Change Control and update related documentation (SOPs, forms, QC records).
- Maintain equipment/instrument readiness (calibration, preventive maintenance, documentation).
- Review/approve QC records and test data per Good Documentation Practices (GDP).
- Support audits/inspections with QC documentation and readiness.
- Track/report reagent QC KPIs.
- Identify and implement process improvements; promote a quality/safety/continuous improvement culture.
- Perform other duties as assigned.
Required Qualifications:
- Bachelor’s degree in a scientific field.
- 5+ years’ experience in a regulated laboratory environment (CLIA, CAP, NYS, FDA, or ISO), including 2+ years performing/overseeing QC or testing.
- Supervisory experience in a laboratory.
- Knowledge of molecular techniques (NGS, PCR, nucleic acid extraction, quantification, related assays).
- Working knowledge of quality systems and reagent QC processes.
- Proficiency in Microsoft Office; experience with LIMS/QMS.
Preferred Qualifications:
- Master’s degree.
- ASCP (MB) or ASQ certification.
- Familiarity with GMP/GLP and GDP.
Other:
- Periodic travel and some evenings/weekends/holidays.
Conditions of Employment:
- Complete pre-employment screening (criminal background check, drug screening, credit check for certain positions, and reference verification).