Clinical Laboratory Quality Control Specialist

Help us change lives

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Clinical Laboratory Quality Control (QC) Specialist I performs and functions within the Technical Laboratory under the guided direction of the Supervisor, Clinical Lab Quality Control, Quality Control Lead, or designee. In this support position, the Clinical Laboratory QC Specialist I ensures daily QC operations are effective and efficient by coordinating with leadership to anticipate and resolve issues related to efficiencies in quality control, and laboratory processes. Under the guidance of the QC Supervisor, this position works cross-functionally with departments such as materials management, Technical Services and Laboratory Systems Development to ensure reagent inventory is maintained within the lab, identify quality and reagent related issues. The QC Specialist I will assist QC Leadership in improving the laboratory processes. The Clinical Laboratory QC Specialist I also supports the laboratory on the bench up to 50% of the time.

Essential Duties

include but are not limited to the following:

• All assigned job duties are performed following laboratory policies and procedures.
• Responsible for running daily QC scripts using statistical software and reviewing generated daily QC data.
• Responsible for identifying quality control issues, errors, and trends and promptly informing QC Specialist II and/or other QC team members of issues identified.
• May be requested to assist QC Specialist II and/or other QC team members in investigation of quality control issues, errors, and trends.
• May be requested to assist QC Specialist II and/or other QC team members in preparation of monthly quality control reports.
• Responsible for performing validations, verifications, and studies under the guidance of the QC Specialist II and/or other QC team members.
• Responsible for obtaining validation, verification, and study data for review.
• May be requested to assist in review of validation, verification, and study data.
• Assists QC Supervisor, QC Lead, and other QC team members in ensuring that all section turn-around times are maintained.
• Assists the QC Supervisor, QC Lead, and other QC team members by escalating concerns and answering technical questions from laboratory staff and others in Exact Sciences labs, as appropriate.
• Prepares QC, proficiency testing, patient, and other specimen types for analysis, analyzer-to-analyzer, and lot-to-lot testing. Ensures acceptability of samples are within guidelines.
• May be requested to assist in troubleshooting of failed proficiency testing surveys.
• Responsible for maintaining adequate inventory of reagents and promptly informing QC Specialist II and/or other QC team members of issues identified with inventory.
• Responsible for acquisition of instrument performance qualifications data and creation of summary report.
• Maintains ethical standards in the performance of testing and in interactions with patients, coworkers, and other health care professionals.
• Assists with knowledge transfer of changes and additions to laboratory procedures, processes, and policies, including methodology and instrument operation.
• May be requested to give lectures or provide demonstrations, provide technical information and/or instruction to clients, new employees, medical students, residents, peers, and the public as requested and where appropriate.
• Contributes to design, research, review and writing of laboratory procedures. Remains informed of procedure updates. Provides constructive criticism for modification of laboratory procedures and policies.
• Supports and complies with the company’s Quality Management System policies and procedures, as well as all regulatory requirements.
• Knowledge of regulatory requirements.
• Maintains open and effective communication with personnel in work team, and with members of other teams throughout the laboratory.
• Demonstrates professional demeanor, in personal appearance and behavior, in all work-related interactions inside and outside of the laboratory. Demonstrates adaptability by embracing changes in the laboratory with a positive attitude.
• Demonstrated ability to respond to stakeholder requests in a professional and timely manner. 
• Exceptional written and verbal communication skills and strong attention to detail.
• Uphold company mission and values through accountability, innovation, integrity, quality,