LC-MS/MS Technologist I

Labcorp•Indianapolis, IN

About The Position

Labcorp Drug Development, the world’s most comprehensive drug development company, dedicated to improving healthcare and improving lives. Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Scheduled Shift: First Shift Monday-Friday Pay Range: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Incumbent performs established procedures for clinical testing as required in all assigned laboratory disciplines. Incumbent is responsible for analyzing specimens whose results are then reported to the sponsor.

Requirements

6 months (minimum) experience performing manual extractions and working with LC-MS/MS systems in production
Bachelor’s degree in a chemical, physical or biological science from an accredited college or university

Nice To Haves

Experience with GC-FID also helpful.

Responsibilities

Prepare samples by manual extraction for LC-MS/MS analysis o Resolve pendings. Retrieve and check specimens against pending list. Document specimen discrepancies. Notify laboratory management when specimen discrepancies are not resolved.
Prepare workstation and instrumentation for the assigned testing.
Properly handle specimens and independently resolve technical specimen issues in preparation for analysis and specimen storage. Contact internal customers for clarification as needed.
Perform instrument maintenance LC-MS/MS and documentation
Receive, open and place in service all reagents/materials according to SOPs.
Prepare and properly label reagent, quality control, calibrator material.
Document implementation of new reagents/materials according to SOPs.
Perform parallel testing, linearity’s, stability, other quality control practices needed to ensure validity of material prior to being placed into service.
Perform inventory control of supplies and reagents as approved by management.
Perform LC-MS/MS instrument and assay troubleshooting
Operate instruments to perform testing in accordance with established written procedures.
Calibrate instruments, equipment and/or assays as required and document.
Perform basic instrument and equipment troubleshooting.
Notify laboratory management when an instrument or equipment does not meet specifications.
Perform data analysis
Performs routine testing and calculations as required.
Resolve routine and non-routine assay problems.
When data is manually entered (e.g. QC, patient data) ensure peer review is performed and documented prior to release of results.
Prepare proper documentation of test results and enter into the information system.
Generate an appropriate audit trail for all activities.
Document and communicate any result reporting problems or inconsistencies to laboratory management.
Complete testing within the expected turnaround time to meet customers’ expectations.
Review and monitor QC for the various analyses and troubleshoot as needed
Perform experiments, as scheduled, for evaluation of new Calibrator and/or QC lots. Summarize results of investigations and compile data for review by management.
Document quality control results. Interpret quality control results according to Westgard rules or other established departmental procedures and accurately document biases, warnings and violations of control values.
Document corrective action for unusual occurrences (e.g. QC violations, instrument related problems).
Perform proficiency testing as needed
Analyze proficiency testing survey samples as patient specimens.
Training
Individual is responsible for maintaining his/her complete up-to-date training file and is accountable for correcting and deficiencies found in his/her training file.
Individual is responsible for ensuring he/she is trained and training is documented prior to performing a task.
The individual successfully completes, as scheduled, competency assessment and ensures competency testing documentation is provided to management for review/retention.
Competently performs department duties as set forth in the department training checklist(s).
May assist in training new employees and follows-up to ensure training is understood.
Attends, as scheduled, department, mandatory and other meetings and training, as required according to training matrices.
Work to achieve partnership with both internal customers and external clients by:
Pull data in a timely manner for review by QA and external clients.
Contribute to the provision of accurate verbal or written response to internal QA and client audit findings. Coordinate, where needed, with other resources to resolve issue.
Researches and prepares a response following investigation for quality purposes. Coordinate, where needed, with other resources to resolve issue.
Research and responds in a timely manner to internal customer inquiries regarding status of test results, retrieval of samples for testing/storage and other needs.
Understand department metrics and goals.
Demonstrate proficiency in applicable computer systems and software.
Adheres to established Safety policies and Universal precaution guidelines at all times. Maintains a clean, organized and safe work environment. Minimizes biohazard waste. Cleans workstation and materials daily.
Takes action for the department when additional responsibilities and opportunities are presented.
Comply with regulatory guidelines and Covance Standard Operating Procedures (SOPs) at all times.
Provide laboratory management with a report of activities upon request.
Other duties as assigned.