Job description

Invivoscribe is an industry pioneer in oncology diagnostics, dedicated to improving the standard of global healthcare 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 in over 160 countries. Our global network of laboratories offer next generation molecular and flow cytometry panels to support our drug development entity and accelerate clinical trials. Our harmonized clinical laboratories offer a menu focused on clinically significant biomarkers which support therapeutic decisions, minimal residual disease (MRD) monitoring, patient stratification, trial enrollment, and the development of companion diagnostics. For 25 years, we have stood at forefront of precision diagnostics, and we’re just getting started!

We are looking to add a QC Scientist, Technical Support to our Quality Control Team. The Quality Control Scientist, Technical Support, is responsible for documenting, investigating, resolving, and trending customer inquiries and complaints related to the Company’s Research Use Only (RUO), General Purpose Reagent (GPR), Analyste Specific Reagent (ASR), Conformitè Europëenne (CE) and In Vitro Diagnostic (IVD) products.

Core Responsibilities Include:

• Serves as a technical lead and a primary point of contact for customers that allege deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of devices manufactured by the Company.
• Troubleshoots irregular product performance.
• Designs and conducts laboratory experiments to support product complaint investigations.
• Assists Sales and Marketing staff with responding to technical inquiries.
• Ensures all customer complaints and inquiries are accurately documented, thoroughly investigated and resolved in a timely manner.
• Reviews inquiry and complaint records.
• Helps trend inquiries and complaints.
• Conducts Field Action and Post Market Surveillance activities.
• Creates, implements, maintains and improves the Standard Operating Procedures (SOPs) and training materials for the department.
• Assists with training new staff.

You Bring:

• Bachelors’ degree in a scientific or other STEM-related discipline and, typically, 5+ years of molecular biology experience in a GMP regulated industry with 1+ year(s) of technical support experience. Equivalent combination of education, certification, and experience may be considered.
• Working knowledge of polymerase chain reactions, gel electrophoresis, capillary electrophoresis, DNA/RNA isolation and purification, cDNA synthesis and Next Generation Sequencing.
• Working knowledge of medical device quality and regulatory requirements including QSR and ISO quality system standards, the IVD Directive, and the IVD Regulation.
• Working knowledge of Failure Mode and Effects Analysis (FMEA).
• Working knowledge of Adobe Acrobat, Illustrator and Photoshop.
• Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint) and the ability to learn new software programs.
• Evidence of Covid-19 vaccination.

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 bonus program, amazing benefit options, a 401k plan with a fully vested employer match, and generous time off benefits that include floating holidays enabling you to take that year-end holiday week, your birthday, your dog’s birthday – you decide!

Invivoscribe is an Equal Opportunity Employer.

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

Job Type: Full-time

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: One location

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