Clinical Lab Associate IV - MRD Accessioning jobs in United States
cer-icon
Apply on Employer Site
company-logo

Exact Sciences · 1 day ago

Clinical Lab Associate IV - MRD Accessioning

Exact Sciences is helping change how the world prevents, detects and guides treatment for cancer. The Senior Clinical Laboratory Associate II is responsible for assisting clinical laboratory scientists, managing daily operations, and leading laboratory associates while ensuring compliance with regulatory guidelines.

BiotechnologyHealth DiagnosticsManufacturingMedical
badNo H1Bnote

Responsibilities

Perform equipment maintenance according to the laboratory’s standard operating procedures (SOPs)
Oversee sufficient inventory of material, supplies, and equipment in the laboratory and order materials and/or equipment from outside vendors with management approval
Oversee and manage the tracking, labeling, and introduction of consumables and reagents from third party manufactures into the analytical laboratory
Communicate with the materials department regarding material or reagent issues; document events properly, and coordinate a plan to resolve identified issues
Initiate outbound communication to internal or external customers to resolve issues related to samples or sample information received in the laboratory
Assist the clinical laboratory scientists with preparation of reagents, sample processing, and plate assembly
Set-up the liquid handling robots (e.g., Tecan, Hamilton) and assist with automated procedures for high complexity testing using the robots
Perform functional testing on designated laboratory equipment, specifically automated sample processing instruments, to ensure proper functionality
Communicate results with laboratory personnel and necessary outside departments, as well as provide recommendation on the release of the instrument for commercial use based on the justification of functional testing results
Perform laboratory environmental monitoring processing individually; including, but not limited to, collection of testing samples and assembly of plates both manually and with automated instrument scripts; analyze, document, report results, and troubleshoot any failures for root cause
Respond to temperature alerts and generate reports using the wireless temperature monitoring system; perform a root cause analysis of deviations and implement a resolution as needed
Lead the laboratory equipment calibration process for all applicable instruments
Document and maintain all records for equipment and instruments accurately
Organize and maintain personnel and training documents, as well as implement changes to the CLA training program when necessary
Abide by CAP, CLIA, HIPAA, FDA, and other state, federal, international, and regulatory guidelines
Perform quality assurance activities; including, but not limited to, internal audits and inspection preparation
Implement necessary process improvement initiatives upon laboratory management approval
Expand job knowledge by participating in continuing education opportunities (e.g., meetings, webinars, or other, upon management approval)
Author, revise, and review standard operating procedures as assigned; generate and implement an engineering change plan (ECP) when necessary
Lead projects under the supervision of a CLS or supervisor while maintaining quality and efficient workflow of daily duties
Coach senior CLAs and CLAs by identifying strengths and gaps, giving constructive feedback, provide training on current and new procedures, and provide peer review feedback for evaluations
Perform job responsibilities of CLA and Senior CLA as needed
Ability to effectively communicate verbally and in writing; apply excellent attention to detail skills
Ability to multi-task and be flexible with tasks and schedules; ability to work independently within a team environment
Ability to divide workload evenly among laboratory assistants in accordance with operational needs and work as part of a team
Ability to be highly detailed and quality oriented when handling patient specimens or other tasks
Ability to learn and follow written procedures; ability to adapt to changes in workflow
Ability to analyze issues and troubleshoot or escalate as necessary
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
Support and comply with the company’s Quality Management System policies and procedures
Maintain regular and reliable attendance
Ability to act with an inclusion mindset and model these behaviors for the organization
Ability to work designated schedule
Ability to work weekends as needed
Ability to work overtime as needed
Ability to lift up to 40 pounds for approximately 5% of a typical working day
Ability to work seated for approximately 40% of a typical working day. Ability to work standing for approximately 60% of a typical working day. Ability to work on a mobile device, tablet, or in front of a computer screen
Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height
Ability to comply with any applicable personal protective equipment requirements
May perform repetitious actions using lab tools
Use of various chemicals may be used to perform duties
At times, stress may be experienced

Qualification

Laboratory automationHigh complexity testingClinical laboratory regulationsLaboratory Information Management System (LIMS)Equipment maintenanceReagent managementProject managementTrainingCoachingCommunication skillsAttention to detailTeamworkAdaptability

Required

Bachelor's Degree in Life Sciences or related field as outlined in the essential duties; or Associates Degree in the Life Sciences or related field as outlined in the essential duties and 2 years of related experience in lieu of Bachelor's degree; or High School Diploma or General Education Degree (GED) and 4 years of related experience in lieu of Bachelor's Degree
5+ years of experience in a laboratory or production work environment
Demonstrated working knowledge of clinical laboratory regulatory requirements
Demonstrated ability to perform the essential duties of the position with or without accommodation
Authorization to work in the United States without sponsorship

Preferred

Experience working in a high-volume laboratory
Experience working in a lab that performs high complexity sample processing
Experience with Laboratory Information Management System (LIMS)
Experience maintaining inventory or resources in an organized manner
Experience in managing projects under minimal supervision and complete assignments as expected
Experience in training clinical laboratory associates on current or new duties
Working knowledge of automated instrument operation and troubleshooting

Benefits

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

Company

Exact Sciences

company-logo
Exact Sciences offers a portfolio of cancer screening and diagnostic tests that span from early detection to treatment monitoring.

Funding

Current Stage
Public Company
Total Funding
$2.75B
2025-06-20Acquired
2024-04-11Post Ipo Debt· $620.7M
2023-02-23Post Ipo Debt· $500M

Leadership Team

leader-logo
Kevin Conroy
Chairman & CEO
linkedin
leader-logo
Aaron Bloomer
Executive Vice President, CFO
linkedin
Company data provided by crunchbase