Clinical Laboratory Associate IV - Wknd AM

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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 Associate IV supports daily clinical laboratory operations by assisting clinical laboratory scientists and providing leadership to clinical laboratory associates.  This role must demonstrate strong initiative, competency, and technical expertise to assist clinical laboratory scientists in automated high complexity sample processing steps, independent automated and manual sample accessioning and preparation, and associated support functions. The CLA IV is expected to have extensive experience in high throughput automated laboratory workflows, deep knowledge of laboratory automation, and a proven ability to proactively lead and contribute to laboratory projects and operational needs. Leveraging this experience, the Clinical Laboratory Associate IV identifies opportunities for process improvement within laboratory operations and workflow and leads the full improvement cycle, including analysis, recommendation, implementation, and effectiveness assessment. 

Shift: Saturday-Monday, 6am-6:30pm

Essential Duties

Include, but are not limited to, the following:

• 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 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 CLAs by identifying strengths and development gaps, delivering constructive feedback, providing training on current and new procedures, and providing  peer review input to support performance evaluations.
• Perform job responsibilities of CLA as needed.
• Ability to effectively communicate verbally and in writing; apply excellent attention to detail skills.
• Ability to m