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Lead Quality Control Specialist in Clinical Laboratory

2 months ago


Madison, Wisconsin, United States Exact Sciences Full time
Transform Lives Through Quality Control
At Exact Sciences, we are dedicated to revolutionizing cancer prevention, detection, and treatment guidance. Our mission is to provide patients and healthcare professionals with the clarity needed for informed decision-making during critical moments.

Position Overview
The Clinical Laboratory Quality Control Lead plays a pivotal role in overseeing quality assurance within the laboratory environment. This position is primarily tasked with supporting the Quality Control Supervisor in the organization, scheduling, and addressing any identified issues related to quality control processes in the laboratory.

Key Responsibilities
  • Thoroughly understand and accurately document all quality control samples required during designated testing intervals (daily, weekly, monthly, annually).
  • Assist in the technical aspects of the role as needed, collaborating with the Quality Control Technical Specialist.
  • Prepare specimens for analysis, ensuring adherence to acceptability criteria independently.
  • Guarantee the quality and promptness of patient test results by identifying, investigating, and interpreting issues related to specimen collection and reporting.
  • Utilize both routine and specialized laboratory procedures and techniques, demonstrating competency in accordance with established protocols.
  • Familiarize oneself with NYSDOH, CLIA, and CAP standards regarding quality control and proficiency testing.
  • Support Quality Control leadership in the development and execution of laboratory procedures, verifications, and validations.
  • Employ quality improvement tools such as root cause analysis and statistical methods.
  • Adhere to safety regulations as outlined in the Clinical Laboratory Safety Manual.
  • Maintain patient confidentiality and uphold ethical standards in all interactions.
  • Contribute to the design and review of laboratory policies and procedures.
  • Stay informed of procedural updates and ensure team members are knowledgeable about changes.
  • Provide training and guidance to new employees and assist in ongoing training for existing staff.
  • Maintain effective communication within the team and across the laboratory.
  • Participate in performance reviews by providing feedback to the Technical Supervisor.
  • Engage with healthcare professionals to resolve issues and interpret lab results.
  • Conduct regular team meetings to ensure alignment and address concerns.
  • Demonstrate strong written and verbal communication skills.
  • Exhibit attention to detail and a professional demeanor in all interactions.
  • Adapt positively to changes within the laboratory environment.
  • Comply with personal protective equipment requirements.
  • Support the company's mission and values through accountability and teamwork.
  • Ensure regular attendance and the ability to work flexible hours as needed.
  • Manage multiple tasks efficiently while maintaining a high standard of quality.
Qualifications
  • Bachelor's degree in Clinical Laboratory Science, Medical Technology, or related fields with requisite coursework in chemistry and biology.
  • 4+ years of laboratory experience, with at least 1 year focused on quality control.
  • ASCP certification eligibility.
  • Authorization to work in the United States without sponsorship.
Preferred Qualifications
  • Certification from a recognized agency such as ASCP.
  • Experience in a Quality Control role within a technical laboratory setting.
  • Background in molecular diagnostics is a plus.