Certifying Scientist

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:  
Level 1
•    Review and process screening batches including, 
o    Review of chain of custody. 
o    Review of screening batch data for error flags and acceptability.
o    Review and complete Custody and Control forms for negative and negative dilute samples.
o    Organize data and file for storage/further review.
•    Recognize the importance of turnaround time and works 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.

Level 2
•    Perform all duties of Certifying Scientist level 1.
•    Complete one of the following objectives for level 2 (order determined by Management to meet business needs):
o    Objective 1: 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.
o    Objective 2: Review LC-MS/MS data for Non-DOT 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.

Level 3
•    Perform all duties of Certifying Scientist level 1 and complete both objectives listed in level 2.

Level 4
•    Perform all duties of Certifying Scientist level 1, 2 and 3.
•    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.

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.

Level 2 – Achieved after 3 months* in Certifying and completion of either DOT SVT training or Confirmation training “Group C-2: Common Batches – Benzodiazepines”

Level 3 – Achieved after 3 months* at Level 2 and completion of both DOT SVT training and Confirmation training “Group C-2: Common Batches – Benzodiazepines”

Level 4 – Achieved after 3 months* at Level 3 and completion of DOT confirmation training.

*3-month requirement may be waived at Lab Management’s discretion.

•    denotes essential job function.

An Equal Opportunity Employer