Reagent Quality Control Specialist ; 1st Shift

Position Summary

The Reagent QC Specialist I - Molecular is responsible for maintaining compliance with regulatory requirements for the QC process for all incoming reagents, including initial inspection upon receipt, verification testing and assessment, and review of final QC paperwork prior to release to the laboratory.

• Maintain compliance with applicable regulatory requirements (CLIA, NYS, CAP, FDA, ISO, etc.).
• Ensure QC testing of incoming reagents/materials is performed and documented per procedures.
• Verify reagent details (product name, lot number, expiration/received dates, etc.) against specifications/receipt records, packing slips, packaging, and material management system.
• Alert relevant departments of discrepancies and help facilitate corrections.
• Own and maintain reagents pending QC; ensure timely follow-up on issues delaying QC.
• Perform molecular QC testing (e.g., NGS, DNA methylation/MGMT, DNA/RNA extractions, DNA/RNA quantification).
• Prioritize urgent reagent QC requests from Supply Chain/Receiving/management.
• Coordinate QC repeats with management/Material Review Board; track repeats in the reagent tracking system.
• Maintain QC storage units (refrigerators/freezers/room-temp cabinets); dispose old reagents properly; follow up on problematic reagents.
• Quarantine problematic reagents when identified; complete quarantine documentation with MRB number as appropriate.
• Answer basic reagent QC process questions for clinical personnel/management.
• Compile and submit QC documents for review/approval.
• Maintain laboratory equipment; notify leadership of maintenance/repairs.
• Identify issues affecting test performance/reporting and take appropriate action.
• Communicate material issues to cross-functional teams; attend team meetings/huddles.
• Complete competency assessments; identify improvement opportunities; accept other duties as assigned.

• Bachelor's degree in a scientific field (or equivalent work experience).
• 1+ years in a regulated laboratory environment (CLIA, NYS, CAP, FDA, ISO, etc.).
• Knowledge of lab safety for biohazards/chemicals and QC procedures/regulations.
• Proficient in Microsoft Office (Word, Excel, Outlook) and business-use internet.
• Able to work Tuesday-Friday 5:30am-4pm.

• Bachelor's or master's degree in a scientific discipline.
• ASCP or ASQ certification.
• NGS and molecular process experience (extraction, PCR, quantification, pyrosequencing).
• Experience executing reagent/material QC; electronic document control and QMS systems.
• Good manufacturing/good documentation practices knowledge.

• Ability to sit/stand/work at a computer for long periods.
• Possible exposure to blood-borne pathogens, extreme temperatures, high noise, fumes, and biohazardous chemicals (e.g., formalin).
• May require lifting/moving reagents/materials up to 25 lbs.

• Job-specific, safety, and compliance training assigned based on job functions.

• Periodic travel and some evenings/weekends/holidays.