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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 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
- High School Diploma or General Education Degree (GED).
- 4 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.
- Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.
Preferred Qualifications
- Associates or Bachelor’s Degree in Life Sciences or a field relevant to the essential duties.
- 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.
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Salary Range:
$42,000.00 - $73,000.00
The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible.
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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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.
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