Certifying Scientist

International Executive Service Corps

Lenexa (KS)

On-site

USD 52,000 - 98,000

Full time

7 days ago

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Benefits offered by this job

Medical, Dental, Vision

Life/AD&D

401(k)

Paid Time Off

Holidays

Tuition Reimbursement

Job summary

The International Executive Service Corps in Lenexa, KS seeks a qualified laboratory professional to review and interpret donor specimen screening results, ensuring accuracy and defensibility while supporting timely release of reports.

The role covers DOT and non-regulated screening, SVT, non-regulated confirmation, and regulated confirmation, with emphasis on chain of custody, data review, and client communication. Strong attention to detail and adherence to regulatory standards are essential.

Qualifications

Doctoral, master's, Bachelor’s, or associate degree in medical/clinical laboratory sciences.
Bachelor’s degree or higher for High Complexity Testing per 42 CFR 493.1489.
Experience as certifying scientist and LC/MS familiarity desirable.
Experience with screening operations and automated analyzers desirable.

Responsibilities

Review and interpret screening and confirmation results for donor specimens to ensure accuracy and defensibility.
Process screening batches including chain of custody review and data review.
Interface with departments to address batch failures and documentation issues.
Answer inquiries from clients and Medical Review Officers regarding results.
Maintain confidentiality and comply with safety regulations.

Skills

PC proficiency

Attention to detail

Communication skills

Time management

Education

Bachelor's degree or higher in medical technology, clinical laboratory, chemical, or biological science

Tools

LC-MS/MS

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.