Position SummaryThe Supervisor - Reagent QC Molecular Operations is responsible for overseeing the daily operations of the molecular reagent quality control (QC) function. This includes supervising QC testing of incoming reagents and materials, ensuring compliance with all applicable regulatory requirements (CLIA, CAP, NYS, FDA, ISO, etc.) and managing reagent release processes. The supervisor provides technical guidance, supports process improvement initiatives, and ensures the accuracy, timeliness, and integrity of QC activities supporting molecular testing workflows.
Job Responsibilities- Supervise daily QC operations for molecular reagents and materials, ensuring all testing is performed according to approved SOPs and regulatory standards.
- Ensure that Quality Control testing of incoming reagents and materials is performed and documented according to applicable procedures.
- Provide technical support and leadership to QC staff performing molecular verification testing, including Next Generation Sequencing (NGS), DNA/RNA extraction and quantification, and other molecular assays.
- Ensure compliance with all applicable laboratory quality and safety regulations (CLIA, CAP, NYS, FDA, ISO).
- Monitor and prioritize workload, ensuring timely testing and release of materials critical to clinical operations.
- Perform or oversee troubleshooting and root cause investigations for QC nonconformances, deviations, and test failures; initiate or contribute to CAPA activities as needed.
- Train and mentor QC personnel, ensuring competency, adherence to SOPs, and ongoing development in molecular QC methods and quality principles.
- Support Change Control implementation and ensuring related documentation (SOPs, forms, QC records) are updated accordingly.
- Maintain equipment and instrument readiness for QC testing, ensuring calibration, preventive maintenance, and documentation are current.
- Review and approve QC records and test data in accordance with Good Documentation Practices (GDP).
- Participate in audits and inspections by providing QC documentation and always ensuring readiness.
- Develop and/or assist with tracking and reporting key performance indicators for reagent QC.
- Identify and implement process improvements to enhance QC efficiency, accuracy, and compliance.
- Promote a culture of quality, safety, and continuous improvement within the Quality Assurance department.
- Perform other duties as assigned.
Required Qualifications- Bachelor's degree in a scientific field (Molecular Biology, Biology, Chemistry, Biochemistry, Medical Laboratory Science, or related).
- Minimum 5+ years of experience in a regulated laboratory environment (CLIA, CAP, NYS, FDA, or ISO), including at least 2 years performing or overseeing QC or testing activities.
- Previous experience in supervisory role within a laboratory.
- Demonstrated understanding of molecular laboratory techniques such as NGS, PCR, nucleic acid extraction, quantification, or related assays.
- Strong working knowledge of quality systems, reagent QC processes, and applicable regulatory standards.
- Proficiency in Microsoft Office Suite (Excel, Word, Outlook) and experience with laboratory or quality management systems (LIMS/QMS).
Preferred Qualifications- Master's degree in a scientific discipline.
- ASCP (MB) or ASQ certification.
- Familiarity with GMP/GLP and Good Documentation Practices (GDP).
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.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
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.
