Clinical Laboratory Scientist II

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.

From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services.

Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.

The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries.

Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

Work Schedule :

Tuesday-Saturday3 : 00pm-11 : 30pm

Basic Function and Scope of Responsibility :

Transplant Genomics Inc. ("TGI") is a molecular diagnostics company committed to improving organ transplant outcomes with non-invasive serial monitoring guided by biomarkers.

TGI's product portfolio of both individual and combined whole blood gene expression and donor derived cell-free DNA testing iscapable of reliably ruling out subclinical kidney rejection and acute rejection in kidney transplant patients.

In addition to kidney transplantation testing, our newest product for liver transplant patients is a blood-based biomarker assay designed to rule out rejection as immunosuppression therapy is optimized.

The Clinical Laboratory Scientist (CLS) performs laboratory testing, preventive maintenance, troubleshooting, calibration of equipment, quality control procedures and is responsible for the validity of test results with a high level of proficiency and in accordance with Eurofins Transplant Genomics standard operating procedures.

Essential Job Duties :

• Examine samples for validity and other requirements (sample type, volume, etc.)
• Perform sample preparation steps which may include specimen pipetting with a high degree of accuracy and precision
• Operate, calibrate and maintain all assigned laboratory equipment and instruments according to standard operating procedures to ensure quality results
• Perform reagents and materials preparation for testing
• Maintain adequate inventory of supplies, reagents and materials needed for testing
• Document remedial action, troubleshooting, quality assurance activities and instrument maintenance
• Adhere to established processing timelines
• Perform data entry into the Laboratory Information Management System (LIMS)
• Label samples and deliver them to proper area(s)
• Retrieve and re-file samples for testing
• Properly store specimens for short term and long term storage
• Aid laboratory personnel in cleaning duties
• Adhere to all quality and safety standards, as well as ensuring compliance with all applicable regulatory agencies
• Adhere to policies and protocols in the lab
• Work closely and communicate with other lab associates to complete daily activities efficiently
• Represent department and the organization favorably and in accordance with established Company standards and associate attributes at all times
• Other duties as assigned by management

Level I CLS - Minimum Requirements :

• Perform laboratory assays in accordance with standard operating procedures
• Operate, calibrate and maintain all laboratory equipment and instruments according to standard operating procedures to ensure quality results
• Maintain adequate inventory of supplies, reagents and materials
• Accept or reject test results in accordance with standard operating procedures
• Document remedial action, troubleshooting, quality assurance activities and instrument maintenance
• Adhere to established processing timelines
• Adhere to all quality and safety standards
• Other duties as assigned by management

Level II CLS - Minimum Requirements :

• General knowledge of Standard Operating Procedure writing, assay theory, and instrumentation
• Orient, mentor and teach clinical laboratory methods, procedures and techniques to new Associates
• Demonstrate effective teamwork skills by knowledge sharing
• Take on formally-assigned additional duties, such as training, as a part of routine job performance
• Participate on special project teams as requested by supervisory staff

Level III CLS- Minimum Requirements :

• Obtain advanced knowledge of standard operating procedures, assays, and instrumentation
• Participate in troubleshooting activities in conjunction with Technical Supervisor
• Volunteer to serve on various committees and panels to the benefit of the laboratory or company in general (e.g. Safety Committee)
• Performs train the trainer and Qualified Personnel responsibilities as assigned

Level Senior - Minimum Requirements :

• The Senior Clinical Laboratory Scientist leads or executes complex special projects outside of a standard CLS scope. For example, lead an audit prep team or process.
• Utilizes extensive company and technical knowledge to participate in audits and defend company practices as needed.

Qualifications

Essential Experience, Knowledge, Skills and Abilities :

• BS or BA in biological, physical, chemical or clinical laboratory science.
• Authorization to work in the Unites States indefinitely without restriction or sponsorship
• Willing to work with potentially infectious human blood and body fluids.
• Ability to work with automated and manual platforms.
• Must possess skills required for aseptic techniques.
• Intermediate level of proficiency with PC based software programs.
• Demonstrates a high level of integrity and honesty in performing tests, documenting test results and maintaining patient, client, employee and laboratory business confidentiality.
• Excellent verbal & written communication skills.
• Analytical judgment, problem solving skills, accuracy and strong detail oriented.
• CLS I - Minimum :
• 1 year clinical laboratory experience in a CLIA certified laboratory with oversight from a Clinical and / or Medical Director in a regulated environment required.
• Ability to safely work with potentially infectious human blood and body fluids utilizing all appropriate personal protective equipment (PPE).
• Must be comfortable with raw specimen handling.
• Ability to read, interpret, and comply with documents such as internal SOPs, operating and maintenance instructions, and company policies.
• Position may require evening and weekend hours.
• Intermediate level of proficiency with PC based software programs.
• CLS II - Fully meets the qualifications of Level I plus the following :
• Minimum 2 years clinical laboratory experience at CLS Level I.
• Experience in a CLIA certified laboratory with oversight from a Clinical and / or Medical Director in a regulated environment required.
• Demonstrates superior understanding of departmental processes.
• Ensure applicable standard operating procedures are being utilized and followed appropriately.
• CLS III - Fully meets the qualifications of Level II plus the following :
• Minimum 6 years clinical / CLIA certified laboratory experience with oversight from a Clinical and / or Medical Director in a regulated environment required.
• CLS Senior - Fully meets the qualifications of Level III plus the following :
• Minimum 9 years clinical / CLIA certified laboratory experience with oversight from a Clinical and / or Medical Director in a regulated environment required.

Physical Requirements :

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead.
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting.
• Ability to continuously operate a personal computer for extended periods of time (4 or more hours).
• Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions.

The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional Information

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work.

We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

To learn more about Transplant Genomics, Inc., please visit the following websitestransplantgenomics.com and www.eurofinsus.com.

What we offer :

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is aM / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.