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.

• 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.

• 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.

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

• 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

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.

• 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 42

CFR
493.1423 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).

Associate Degree and High School Diploma: training/experience as specified in 42

CFR
493.1489

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…