Quality Control Laboratory Associate I

INVIVOSCRIBE INC•San Diego, CA

18h•Hybrid

About The Position

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 30 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 30 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Quality Control Laboratory Associate I. The QC Lab Associate I is responsible for ensuring that only quality products are released for distribution. It is a QCLAI’s job to ensure that products are tested to meet the applicable government regulations and industry standards, and to maintain GMP environment. The Quality Control Laboratory Associate is also responsible for data entry.

Requirements

B.S. degree in a scientific discipline and, typically, 0-2 year(s) of applicable experience; equivalent combination of education and experience may be considered.
Proficient computer skills and good working knowledge of Microsoft Office programs (Word, Outlook, Excel and PowerPoint) and the ability to learn new software programs to include Adobe Acrobat, Illustrator, and/or Photoshop.

Nice To Haves

Internships and/or other related experience preferred.
Familiarity wtih polymerase chain reactions, gel electrophoresis, capillary electrophoresis, next generation sequencing, DNA/RNA isolation and purification, and cDNA synthesis is preferred.
Familiarity with 3500xl Dx, ABI 7500 Dx, PGM Dx, S5 Dx, MiSeq Dx, BioTek plate fluorometer, QiaCube, 2100 Bioanalyzer, NanoDrop Spectrophotometer, iBright, and single and multichannel pipettes.
Familiarity with medical device quality and regulatory requirements including QSR and ISO quality system standards, the IVD Directive and IVD Regulation is preferred.

Responsibilities

Effectively maintain the Standard Operating Procedures (SOP), acceptance criteria, etc. for the department and products tested.
Effectively and efficiently test raw materials, in process, and final products, and generate testing data.
Conduct and maintain the real time stability study testing.
Maintain inventory materials used in quality control.
Compile QC related data and maintain the database.