Clinical Laboratory QC Specialist Job at Exact Sciences (Madison)

Job Description

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.

Job Responsibility

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, and teamwork
Regular and reliable attendance
Ability to work overtime as needed
Ability to work nights and/or weekends as needed
Ability to lift and move up to 40 pounds for approximately 25% of a typical working day
Ability to walk, bend and reach for up to 100% of a typical working day
Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day
Ability to grasp with both hands
pinch with thumb and forefinger
turn with hand/arm
reach above shoulder height
Ability to listen and speak on the telephone and write simultaneously
Ability to operate telephone system and computer keyboard and mouse
Vision: Adequate to perform the essential functions of the job such as read and perform lab tests
Hearing: Adequate to perform the essential functions of the job such as hear timer alarms, etc
Speaking: Strong ability to perform the essential functions of the job such as communicating with staff, patients, colleagues, and providers
Dexterity: Adequate to perform the essential functions of the job including operating a computer
Mental Demands: Adequate to perform the essential functions of the job such as the stress of reporting STAT lab work and performing multiple lab tests simultaneously
Ability to comply with any applicable personal protective equipment requirements
Travel between Madison Laboratory locations may be required

Requirements

Bachelor’s degree in chemical, biological, or clinical laboratory sciences or medical technology from an accredited institution
For a degree not one of those listed above: 90 semester hours which must include 16 semester hours in chemistry (6 of which must be in inorganic chemistry)
16 semester hours in biology courses and 3 semester hours of math
2+ years of experience in a laboratory setting
1+ years of experience performing, reviewing and understanding quality control on a routine basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Authorization to work in the United States without sponsorship

Nice to have

1+ years of molecular diagnostic laboratory experience
3+ years of relevant experience within a technical laboratory

What we offer

paid time off (including days for vacation, holidays, volunteering, and personal time)
paid leave for parents and caregivers
a retirement savings plan
wellness support
health benefits including medical, prescription drug, dental, and vision coverage
bonus eligible

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Clinical Laboratory QC Specialist

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