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Quality Control Laboratory Associate I
2 months ago
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 Quality Control Laboratory Associate I to our Quality Control Team. The Quality Control Laboratory Associate I 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.
Core Responsibilities Include:
- Effectively maintain the Standard Operating Procedures (SOP) acceptance criteria etc. for the departmental and products tested.
- Effectively and efficiently test raw materials, in process and final product 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.
- 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. Internships and/or other related experience preferred.
- Meticulous attention to detail and strong analytical skills are desired.
- 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.
- 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. Familiarity with JMP, Oracle Cloud or other ERP systems is beneficial.
- A beautiful modern facility centrally located in San Diego County.
- 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.
Invivoscribe is an Equal Opportunity Employer.
