Invivoscribe
Quality Control Laboratory Associate I
Invivoscribe, San Diego, California, United States, 92189
Invivoscribe is an industry pioneer dedicated to Improving Lives with Precision Diagnostics. For over 25 years, Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments.
Headquartered in sunny San Diego, California, with locations across the world, we offer a comprehensive portfolio of products and services. We collaborate with key partners to develop molecular assays, reagents, controls, and bioinformatics tools under ISO 13485 design control, used by over 700 clinical laboratories in more than 160 countries.
Our global network of laboratories provides internationally standardized next-generation molecular and flow cytometry panels to support drug development and expedite drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies to develop companion diagnostics, essential for gaining approval of new cancer treatments. Our ISO15189 accredited and CLIA/CAP clinical laboratories focus on biomarkers that are clinically actionable, supporting therapeutic decisions, MRD testing, patient stratification, and trial enrollment, all aimed at accelerating new oncology drug approvals.
We have been at the forefront of precision diagnostics for 25 years and are just getting started!
We are looking to add a
Quality Control Laboratory Associate I
to ensure that only quality products are released for distribution. The role involves testing products to meet government regulations and industry standards, maintaining a GMP environment, and data entry.
Core Responsibilities Include:
Maintaining Standard Operating Procedures (SOPs) and acceptance criteria for the department and tested products.
Testing raw materials, in-process, and final products, and generating testing data.
Conducting and maintaining real-time stability study testing.
Maintaining inventory of materials used in quality control.
Compiling QC data and maintaining the database.
You Bring:
B.S. degree in a scientific discipline with 0-2 years of applicable experience; equivalent education and experience may be considered. Internships or related experience are preferred.
Familiarity with PCR, gel electrophoresis, capillary electrophoresis, NGS, DNA/RNA isolation, and cDNA synthesis is preferred.
Experience with equipment such as 3500xl Dx, ABI 7500 Dx, PGM Dx, S5 Dx, MiSeq Dx, BioTek plate fluorometer, QiaCube, 2100 Bioanalyzer, NanoDrop, iBright, and pipettes.
Knowledge of medical device quality and regulatory standards including QSR, ISO, IVD Directive, and IVD Regulation is preferred.
Proficiency in Microsoft Office and ability to learn new software like Adobe Acrobat, Illustrator, and Photoshop.
We Bring:
A modern facility in San Diego County with flexible scheduling and telework options.
A welcoming breakroom with beverages and healthy snacks, and a micro-market.
A positive, supportive, and inclusive workplace culture.
Opportunities to learn, grow, and connect with colleagues.
Competitive pay, bonuses, stock options, benefits, 401k with employer match, and generous time off.
Invivoscribe is an Equal Opportunity Employer.
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Headquartered in sunny San Diego, California, with locations across the world, we offer a comprehensive portfolio of products and services. We collaborate with key partners to develop molecular assays, reagents, controls, and bioinformatics tools under ISO 13485 design control, used by over 700 clinical laboratories in more than 160 countries.
Our global network of laboratories provides internationally standardized next-generation molecular and flow cytometry panels to support drug development and expedite drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies to develop companion diagnostics, essential for gaining approval of new cancer treatments. Our ISO15189 accredited and CLIA/CAP clinical laboratories focus on biomarkers that are clinically actionable, supporting therapeutic decisions, MRD testing, patient stratification, and trial enrollment, all aimed at accelerating new oncology drug approvals.
We have been at the forefront of precision diagnostics for 25 years and are just getting started!
We are looking to add a
Quality Control Laboratory Associate I
to ensure that only quality products are released for distribution. The role involves testing products to meet government regulations and industry standards, maintaining a GMP environment, and data entry.
Core Responsibilities Include:
Maintaining Standard Operating Procedures (SOPs) and acceptance criteria for the department and tested products.
Testing raw materials, in-process, and final products, and generating testing data.
Conducting and maintaining real-time stability study testing.
Maintaining inventory of materials used in quality control.
Compiling QC data and maintaining the database.
You Bring:
B.S. degree in a scientific discipline with 0-2 years of applicable experience; equivalent education and experience may be considered. Internships or related experience are preferred.
Familiarity with PCR, gel electrophoresis, capillary electrophoresis, NGS, DNA/RNA isolation, and cDNA synthesis is preferred.
Experience with equipment such as 3500xl Dx, ABI 7500 Dx, PGM Dx, S5 Dx, MiSeq Dx, BioTek plate fluorometer, QiaCube, 2100 Bioanalyzer, NanoDrop, iBright, and pipettes.
Knowledge of medical device quality and regulatory standards including QSR, ISO, IVD Directive, and IVD Regulation is preferred.
Proficiency in Microsoft Office and ability to learn new software like Adobe Acrobat, Illustrator, and Photoshop.
We Bring:
A modern facility in San Diego County with flexible scheduling and telework options.
A welcoming breakroom with beverages and healthy snacks, and a micro-market.
A positive, supportive, and inclusive workplace culture.
Opportunities to learn, grow, and connect with colleagues.
Competitive pay, bonuses, stock options, benefits, 401k with employer match, and generous time off.
Invivoscribe is an Equal Opportunity Employer.
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