Certifying Scientist

International Executive Service Corps; Lenexa (KS); On-site; USD 34,000 - 65,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life/AD&D

401(k)

Job summary

International Executive Service Corps seeks a qualified laboratory specialist to review screening and confirmation data, ensuring accuracy and defensible results. The role requires managing chain of custody, data organization, and coordination across departments to enable timely reporting.

The position emphasizes proficiency with LC-MS/MS data, SOP understanding, and strong communication for client inquiries and regulatory compliance.

Qualifications

• Doctoral, master’s, bachelor’s, or associate degree in medical technology, clinical laboratory, chemical, or biological science.
• High Complexity Testing: Bachelor’s Degree or higher as per 42 CFR 493.1489.
• Acting Technical Supervisor: degree in chemical/biological/clinical lab science with relevant experience.

Responsibilities

• Review and interpret screening results and ensure forensic defensibility.
• Process and review chain of custody and data for batches.
• Interface with departments to address batch failures and document issues.
• Communicate results to clients and Medical Review Officers as needed.
• Maintain confidentiality of client information and comply with safety regulations.

Skills

PC literacy

SOPs

Attention to detail

Communication

Punctuality

Team interaction

Education

Doctoral degree

Master’s degree

Bachelor’s degree

Associate degree

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.

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.

denotes essential job function.

An Equal Opportunity Employer

Pay Range:

$25.00 - $47.00

Benefits for Full Time Employees:

• Medical, Dental, Vision
• Life/AD&D
• Supplemental Life/AD&D
• Section 125 FSA Plan
• 401(k)
• Short and Long-Term Disability
• Paid Time Off
• Holidays
• Tuition Reimbursement