Quality Control Laboratory Associate II

Invivoscribe is an industry pioneer and global leader in precision oncology diagnostics. For more than 30 years we have driven international standardization of molecular and flow cytometry testing and expanded access to advanced cancer therapies worldwide. Our mission is simple and unwavering: Improving Lives with Precision Diagnostics ®

We are looking to add a Quality Control Laboratory Associate II, who will be responsible for ensuring that only quality products are released for distribution. It is a QCLAII’s job to ensure that products are tested to meet the applicable government regulations and industry standards. The Quality Control Laboratory Associate II is also responsible for assisting investigations, stability studies, projects, Field Actions, post-market surveillance, statistical quality control activities, and maintenance of GMP environment. This position is also responsible for resolving customer inquiries and complaints.

Headquartered in San Diego, with operations across North America, Europe, and Asia, Invivoscribe develops and manufactures a comprehensive portfolio of molecular and flow cytometry assays, reagents, controls, and bioinformatics tools under ISO 13485 design control. Our products and services support more than 700 clinical laboratories in over 160 countries.

Core Responsibilities Include:  

• Effectively maintains the Standard Operating Procedures (SOP), acceptance criteria, etc., for the department and the products tested.
• Effectively and efficiently executes testing to support QC release or stability assessment of raw reagents, and in- process and final products. 
• Assists with Installation Qualification (IQ)/ Operational Qualification (OQ)/ Performance Qualification (PQ) and validations.
• Assists with troubleshooting and root cause analysis.
• Assists in addressing and documenting product inquiries and complaints, including analysis, troubleshooting, and completing complaint documentation. 
• Assists with record review for accuracy and completeness.
• Assists with post-market surveillance and Field Action Assessments (FAAs).
• Maintains Quality Control reagent inventory, including execution of electronic transactions and adjustments.
• Assists with statistical quality control activities.

You Bring:

• B.S. degree in a scientific discipline and, typically, 2 years of experience in biotechnology, chemistry, or pharmaceutical QC laboratory to include 1 year(s) of molecular biology experience in a GMP regulated industry. Equivalent combination of education and experience will be considered.
• Equivalent combination of education and experience may be considered.
• Working knowledge of polymerase chain reactions, gel electrophoresis, capillary electrophoresis, next generation sequencing, DNA/RNA isolation and purification, and cDNA synthesis.
• Working knowledge of the following equipment is preferred: 3500xl Dx, ABI 7500 Dx, PGM Dx, S5 Dx, MiSeq Dx, BioTek plate fluorometer, QiaCube, 2100 Bioanalyzer, LabChip Gx, NanoDrop Spectrophotometer, iBright, and single and multichannel pipettes.
• Working knowledge with medical device quality and regulatory requirements including QSR and ISO quality system standards, the IVD Directive and the 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.

We Bring:

• A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options.
• A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day.
• A positive workplace culture with an emphasis on support, respect and belonging.
• A diverse and inclusive work environment where you will learn, grow, and make new friends.
• Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits.

Invivoscribe is an Equal Opportunity Employer.