Clinical Laboratory Scientist II

Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics.
Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years.
Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services.
We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries.
Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide.
We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients.
Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments.
For 25 years, we have been at forefront of precision diagnostics, and we're just getting started!
We are looking to add a Clinical Laboratory Scientist II for performing specialized high complexity testing of biological specimens.
This position provides professional customer service to our clients.
CLS works in a team environment to ensure timely and quality test results.
The CLS II works with guidance as needed to changes in the workflow.
Core Responsibilities Include:

Performs all assigned duties in compliance with internal SOPs and external regulations.
Brings compliance issues to the attention of management.
Performs all aspects of pre-analytic workflow to ensure orders are entered correctly, specimens collected are appropriate for the test ordered and are correctly processed.
Evaluates specimens for appropriateness and takes necessary corrective action.
Appropriately documents unacceptable specimens.
Performs all aspects of the clinical testing workflow including:
Semi-automated and manual DNA isolations.
Quantify and normalize isolated DNA.
Operate laboratory equipment, such as Thermocyclers, Next Generation testing platforms, cell counters, UV-Vis Spectrophotometer, fluorometer, electrophoresis testing platforms, etc.
Use automated equipment that analyzes multiple samples at the same time.
Performs NGS Library Preparation which can then be sequenced on an NGS Testing Platform.
Performs complex gene panel NGS tests.

Verifies reagents and supplies, meets defined acceptability criteria upon receipt and prior to use and acts to ensure unacceptable items are removed from use.
Assist with inventory counting.
Prioritizes testing based on assignment or established priorities; completes testing within defined turn-around times.
Performs technical review, data analysis and interpretation.
Reviews results for completeness, correctness and consistency within defined test system.
Performs moderate to advanced troubleshooting and repair.
Escalates issues when necessary.
Recognizes when unresolved problems need to be escalated and takes necessary follow-up action.
Performs all aspects of the post-analytic workflow appropriate to ensure accurate results are reported within established time frames, specimens are retained appropriately, test results and/or current status are available upon inquiry.
Assists with required Quality Management System responsibilities including initiating Quality Occurrence Reports.
Follows all required safety procedures, assumes a proactive role in laboratory safety.
Follows all required privacy, safety, and biohazard procedures and standards.
May assist with training of new employees.
Responsible for monitoring and troubleshooting temperature excursions on cold storage units.
Follows all proficiency testing (PT) policies and guidance.
Performs Phase-ins (also known as Prequalification of Reagents or Reagent QC).
Ensures HIPPA laws are followed.
Ensures patient, and employee confidentiality.
Ensures supply and reagent levels are at the appropriate levels and notifies appropriate personnel when new supplies are needed.
Ensures integrity of Laboratory Information Management System (LIMS) by following established protocols and participating in the maintenance and enhancements of the LIS.
You Bring:

BS in Clinical Laboratory Science or scientifically related field with, typically, 2+ years of industry experience in a Clinical Laboratory.
Equivalent combination of education and experience will be considered.
Licensed in California as a Clinical Laboratory Scientist.
Proficient computer and Microsoft Office program skills (Word, Outlook, Excel), and the ability to learn new software programs.
We Bring:

A beautiful modern facility centrally located in San Diego County, with many jobs conducive to a hybrid work from home arrangement.
A safe, fully-vaccinated, work environment.
A diverse and inclusive work environment where you will learn, grow, and make new friends.
A well-stocked breakroom with hot and cold beverages, snacks, refrigerator and pantry items to get you through the day.
Competitive salaries and discretionary bonus program, incentive stock options, amazing benefit options, a 401k plan with a fully vested employer match, and generous time off benefits that include floating holidays.

Invivoscribe is an Equal Opportunity Employer.

Evidence of COVID-19 vaccination will be required as a condition of employment.
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