Certifying Scientist

Clinical Reference Laboratory

Lenexa (KS)

On-site

USD 34,000 - 65,000

Full time

4 days ago

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Benefits offered by this job

Medical, Dental, Vision

401(k)

Paid Time Off

Tuition Reimbursement

Overtime

Job summary

Clinical Reference Laboratory is seeking a detail‑oriented scientist to review and interpret donor screening and confirmation results. You will ensure accuracy, forensic defensibility, and timely release of reports while maintaining strict custody and data integrity.

The role requires strong communication, adherence to SOPs, and collaboration with multiple departments to resolve issues. Prior LC/MS experience and high complexity testing background are highly valued.

Qualifications

Bachelor’s or higher in a chemical/biological/clinical laboratory science or medical technology.
Experience with LC/MS and screening operations is highly desirable.
Strong attention to detail and ability to work under pressure.

Responsibilities

Review and interpret screening and confirmation results for donor specimens.
Ensure accuracy and forensic defensibility of results.
Maintain custody and control documentation and data organization.
Interface with departments to direct corrective action for issues.
Answer inquiries from clients and Medical Review Officers about status and analysis.
Communicate clearly as an expert when explaining accessioning, screening, LC/MS/MS data, or legal challenges.

Skills

Familiarity with PC

Detail oriented

Good communication skills

SOP comprehension

Ability to work under pressure

Education

Bachelor’s degree in chemical/biological/clinical lab science or medical technology

Tools

LC/MS

Automated analyzers

Job description

GENERAL STATEMENT OF RESPONSIBILITY

Review and interpret screening and confirmation results for donor specimens to ensure accuracy and forensic defensibility of results, and work towards a team goal of timely release of result reports.

ESSENTIAL FUNCTIONS

DOT and Non-Regulated Screening

Review and process screening batches including,
Review of chain of custody.
Review of screening batch data for error flags and acceptability.
Review and complete Custody and Control forms for negative and negative dilute samples.
Organize data and file for storage/further review.
Recognize the importance of turnaround time and work toward the timely release of specimens.
Interface cooperatively and clearly with all departments to direct corrective action in the event of a batch failure, incomplete/improper chain of custody documentation, computer problems related to the reporting of results, etc.
Answer incoming phone calls/emails and assist clients and Medical Review Officers regarding the status and analysis of results.
Communicate clearly as an "expert" when called upon to explain any/all aspects of accessioning, screening, review of screening and/or LC/MS/MS data, etc., by an inspector or in the event of a legal challenge.
Maintain and protect the confidentiality of all CRL, CRL subsidiaries, legal entities and client information.
Be able to comply with all applicable federal, state, and local safety and health regulations that would apply to this job.
Keep work area neat and clean.

Other duties as assigned.

DOT and Non-Regulated SVT

Review and process Specimen Validity Testing (SVT) results including:
Review of chain of custody.
Review and interpretation of SVT data.
Request follow up testing as appropriate.
Completion of Custody and Control forms for negative, negative dilute, invalid, adulterated, and substituted DOT samples.
Organize data and file for further review and storage.

Non-Regulated Confirmation

Review LC-MS/MS data for Non-Regulated confirmation batches including:
Review of chain of custody.
Review of raw data for acceptability.
Review and certification of results.
Release of samples with completed testing.

Regulated Confirmation

Review all batches associated with a donor sample before release including screening, LC-MS/MS, and SVT batches.
Review and completion of Custody and Control forms for completed specimens.

Hair Screening and Confirmation

Perform screening certification and confirmation certification procedures for Hair Lab specimens

The order in which each level may be achieved is determined according to business needs, certifications, and experience and is not necessarily progressive.

Achievement in each area is based on demonstrated competency and required training.

Job Qualifications

EDUCATION: A doctoral, master’s, bachelor’s, or associate degree in medical technology, clinical laboratory, chemical, or biological science.

Experience

High Complexity Testing: Bachelor’s Degree or higher: training/experience as specified in 42CFR493.1489

Acting Technical Supervisor:

Education: Bachelor’s degree in a chemical or biological or clinical laboratory science, or medical technology from an accredited institution or equivalent. Experience: 4 years of pertinent laboratory experience.

Prior experience as a certifying scientist highly desirable; LC/MS experience highly desirable; experience with screening operations highly desirable; experience with automated analyzers desirable.

Skills & Abilities

Familiarity with PC
Must be able to read, understand, and develop strong working knowledge of appropriate SOP’s and other relevant information services
Detail oriented; strong analytical and organizational skills
Good communication skills; ability to work under pressure
Ability to be at work and on time
Ability and judgment to interact and communicate appropriately with other employees, clients and management

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be available to enable qualified individuals with disabilities to perform the essential functions.

The Following Physical Attributes Are Required For This Position

Sitting for extended lengths of time
Close vision requirements due to computer work
Repetitive use of hands, fingers, wrists, and elbows for operating a computer and telephone
Light lifting, up to 10 pounds
The ability to discriminate between different colors visually is considered an essential function for the position.

EQUIPMENT:

PC, calculator

OTHER:

Overtime, weekends, nights as required.

The employer shall, in its discretion, modify or adjust this position to meet the company’s changing needs.

This job description is not a contract and may be adjusted as deemed appropriate in the employer’s sole discretion.