Reagent Quality Control Specialist I

About the Role

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. This 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.

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.
• Review/verify 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.
• Alert applicable departments when discrepancies are detected and help facilitate corrections of errors as needed.
• Own and maintain all reagents pending QC, ensuring all QC testing is done in a timely manner.
• Continuously follow up on any issues delaying QC to ensure all reagents are tested promptly.
• Perform Molecular Department testing, including Next Generation Sequencing, DNA Methylation analysis (MGMT), DNA/RNA extractions, and/or DNA/RNA quantification.
• Prioritize QC for reagents needed urgently as requested by Supply Chain, Receiving, or management.
• Take direction from management and the Material Review Board when QC repeats are needed and track all repeat testing within the reagent tracking system.
• Maintain all reagent QC storage units (refrigerators, freezers, and room temperature cabinets) to ensure they are clean, organized, and any old reagents are properly disposed of.
• Quarantine any problem reagents found within the laboratory reported by clinical personnel and complete applicable documentation.
• Answer basic questions regarding the reagent QC process from clinical personnel or management as needed.
• Compile and submit Quality Control documents for review/approval by Departmental partners.
• Maintain laboratory equipment and ensure it is in proper working order, notifying leadership if maintenance and/or repairs are needed.
• Identify problems that may adversely affect test performance or reporting of test results and take appropriate action.
• Communicate material issues to cross-functional teams as necessary.
• Participate in regular team meetings/huddles as requested by department management.
• Maintain/complete applicable competency assessments.
• Identify opportunities for improvement.
• Accept other duties as assigned.

Qualifications

• Bachelor's degree in a scientific field (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.
• Proficiency in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of the Internet for business use.

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

• 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.

Other

This position requires periodic travel and some evenings, weekends, and/or holidays. Conditions of employment include successfully completing a pre-employment process, which includes a criminal background check, drug screening, credit check (applicable for certain positions), and reference verification.