Confirmation Chemist

GENERAL STATEMENT OF RESPONSIBILITY: Perform duties related to sample preparation, submissions, and/or data review with strict adherence to departmental procedures; work in compliance to departmental safety requirements consistent with good laboratory practices.

ESSENTIAL FUNCTIONS:

Level 1

• Receive and prepare samples for instrumentation
• Receive samples from confirmation sorter and passthrough for testing.
• Prepare samples per SOP using manual and automated pipetting, including dilutions.
• Maintain chain of custody throughout process.
• Read and follow laboratory SOPs.
• Recognize the importance of quality and work toward the highest standard possible when processing samples, able to identify and communicate needed improvements.
• Recognize the importance of turnaround time and work toward the timely processing of samples, able to prioritize work as needed.
• Operate, monitor, clean, maintain, calibrate, troubleshoot, and record needed documentation on instrumentation: Tecan, manual single and multi-channel pipettors, balance, evaporation manifolds, heat blocks, refrigerator, freezer, temperature monitoring system, glassware.
• Maintain and distribute supplies: reagents, controls, re-filling/re-furbishing materials needed, notify management of items needed, receive and stock.
• Comply with safety regulations in the proper use, labeling, and handling of equipment and materials.
• Meet qualitative and quantitative production goals of the department.
• Communicate with department members to ensure maximum production.
• 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. Follow departmental clean up procedures in disposal of hazardous chemicals and waste.

Other duties as assigned.

Level 2

• Perform all duties of Confirmation Chemist level 1.
• Complete one of the following objectives for level 2 (order determined by Management to meet business needs):
  • Objective 1: Load batches on analytical instrumentation (LC-MS/MS, GC-FID) including:
    • Prepare instrument for run, prime, load sequence
    • Perform minor instrument troubleshooting
• Operate, monitor, maintain, and record needed documentation on LC-MS/MS, GC-FID, and Q-TOF instrumentation
• Balance loading of instruments to maximize production
• Maintain chain of custody throughout process.
• Objective 2: Data review of all confirmation batches including Phases 1-3:
  • Review calibration, quality control, and patient samples in accordance to chromatography acceptance criteria. Troubleshoot non-compliant results.
  • Assemble batch for review.
  • Accurately enter patient results.
  • Submit data package to certification.
  • Maintain chain of custody throughout process.

Level 3

• Perform all duties of Confirmation Chemist level 1 and complete both objectives listed in level 2.

Level 4

• Perform all duties of Confirmation Chemist level 1, 2, and 3.
• Data review of all confirmation batches including Phase 4
• Certify LC-MS/MS screening batches

JOB QUALIFICATIONS:

EDUCATION: A doctoral, master's, bachelor's, or associate degree in medical technology, clinical laboratory, chemical, physical, or biological science or high school diploma or equivalent.

EXPERIENCE:

• Moderate Complexity Testing:

High School Diploma: a) Successfully completed military training of 50 or more weeks and served as a medical laboratory specialist; OR

b) Appropriate training/experience as specified in 42CFR493.1423 and/or 90 Semester Hours Requirements for New York State (16 hours Chemistry, 6 hours Inorganic Chemistry, 16 hours Biology pertinent to medical sciences, 3 hours Mathematics. 1 year training covering several fields of medical laboratory work).

High Complexity Testing:

Associate Degree and High School Diploma: 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.

• Previous laboratory experience.
• Familiarity with sample preparation and/or LC/MS/MS preferred.

SKILLS & ABILITIES:

• Good verbal and written communication skills
• Strong organizational skills
• Ability to work under time constraints
• Detail oriented
• Good judgment and decision-making skills
• Ability to follow instructions precisely
• Good laboratory technique
• 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
• Regularly required to move around laboratory
• Close vision requirements due to computer work
• Repetitive use of hands, fingers, wrists, and elbows for operating a computer and telephone
• Reaching, including above the shoulder
• Bending or stooping
• Squatting or crouching
• Kneeling
• Climbing
• Lifting up to 25 pounds

EQUIPMENT: Must operate and maintain automated testing instrumentation. Automated pipettors, centrifuge; shaker/rotator; heating block; pH meter; analytical balance; various automated instruments; pipette; lab coat; gloves; gas cylinders; PC; LC/MS/MS.

OTHER: Overtime as necessary; weekend work is required; specimens consist of body fluids and must be regarded as potentially infectious; exposure to caustics, flammables, solvents, carcinogens, and reactive compounds.

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

This 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: $24.00 - $46.00

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