Clinical Lab Associate IV - MRD Accessioning

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Position Overview

The Senior Clinical Laboratory Associate (CLA) II is responsible for assisting the clinical laboratory scientists and supporting the daily operations of the clinical laboratory, as well as working in a leadership role to clinical laboratory associates. They must demonstrate the initiative, skills, competency, and knowledge base to assist clinical laboratory scientists in automated high complexity sample processing steps, independent automated and manual sample accessioning and preparation, and all other support functions. They must have extensive experience and an excellent understanding of a high throughput automated laboratory workflow, in depth knowledge of laboratory automation, and the track record of continuous initiative to lead and contribute to laboratory projects and to address laboratory needs and issues proactively. The Senior CLA II is expected to use their knowledge and experience to identify process improvements in laboratory operations and workflow and lead the process improvement plan through its completion; including, but not limited to, analysis, recommendation, implementation, and effectiveness check.

This role possesses the technical skill and thorough understanding of automated laboratory processing and performs functional testing of automated instrumentation, as well as determines and communicates whether the instrument is performing correctly with clinical laboratory scientists and service engineers. The Senior CLA II is expected to oversee the procurement, tracking, labeling, and identification of reagents and consumables entering the laboratory from outside manufacturers and communicate and properly introduce these reagents and consumables into the analytical laboratory while following all necessary regulatory requirements and operating procedures. The Senior CLA II serves as a leader to the CLA team to coordinate tasks, divide workload, oversee projects, provide guidance, and review, edit, and author documents as assigned.

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, 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.

Minimum Qualifications

• 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 Qualifications

• 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.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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