LCMS Analyst II
Join us and discover why Labcorp Drug Development has been named by Fortune® Magazine as one of the World's Most Admired Companies 2022 for the fourth consecutive year, by Forbes as one of the World's Best Employers 2020 and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career.
What to Expect:
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.
o Prepare workstation and instrumentation for the assigned testing.
o 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
o Receive, open and place in service all reagents/materials according to SOPs.
o Prepare calibrators, QC, standards, reagents and mobile phase as outlined in each analyte SOP
o Document implementation of new reagents/materials according to SOPs.
o Perform parallel testing, linearity’s, stability, other quality control practices needed to ensure validity of material prior to being placed into service.
o Perform inventory control of supplies and reagents as approved by management.
Perform LC-MS/MS instrument and assay troubleshooting
o Operate instruments to perform testing in accordance with established written procedures.
o Calibrate instruments, equipment and/or assays as required and document.
o Perform basic instrument and equipment troubleshooting.
o Notify laboratory management when an instrument or equipment does not meet specifications.
Perform data analysis
o Performs routine testing and calculations as required.
o Resolve routine and non-routine assay problems.
o When data is manually entered (e.g. QC, patient data) ensure peer review is performed and documented prior to release of results.
o Prepare proper documentation of test results and enter into the information system.
o Generate an appropriate audit trail for all activities.
o Document and communicate any result reporting problems or inconsistencies to laboratory management.
o Complete testing within the expected turnaround time to meet customers’ expectations.
Review and monitor QC for the various analyses and troubleshoot as needed
o Review and investigate unacceptable results to internal and external quality control monitoring programs. Prepare corrective action responses by assigned due date for management review.
Perform proficiency testing as needed
o May provide support to proficiency testing program by coordinating receipt of survey material, coordinating with interdepartmental personnel for sample analysis, and ensuring timely and correct completion of electronic or paper report forms.
o Investigate root cause for unacceptable performance on proficiency surveys and prepare corrective action response by assigned due date.
o Complete timely review of new or revised SOPs circulated for peer review.
o May assist with timely processing of SOPs for department.
o 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.
o Individual is responsible for ensuring he/she is trained and training is documented prior to performing a task.
o The individual successfully completes, as scheduled, competency assessment and ensures competency testing documentation is provided to management for review/retention.
o Competently performs department duties as set forth in the department training checklist(s).
o May assist in training new employees and follows-up to ensure training is understood.
o Attends, as scheduled, department, mandatory and other meetings and training, as required according to training matrices.
o May assist with the development of training material, training checklists, and competency assessment programs.
Work to achieve partnership with both internal customers and external clients by:
o Pull data in a timely manner for review by QA and external clients.
o 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.
o Researches and prepares a response following investigation for quality purposes.
Coordinate, where needed, with other resources to resolve issue.
o 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.
o Understand department metrics and goals.
Assist staff by providing technical guidance where needed.
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.
1 year (minimum) experience performing manual extractions and working with LC-MS/MS systems in production: Experience with GC-FID also helpful.
Education/Qualifications/Certifications and Licenses
Bachelor’s degree in a chemical, physical or biological science from an accredited college or university
Benefits: 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. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please [Register to View] .