Carlsbad, California, USA
6 days ago
Quality Control Specialist I - Data Analysis

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Always innovating, we bring together dedicated people and diverse perspectives from across our global network, empowering each other to keep breaking new ground. We are Roche.

The Opportunity

In this position, you are conducting signal data analysis for tested products. You will investigate, troubleshoot and document out-of-trend data discovered during signal analysis. As QC Specialist, you will also conduct incoming, in-process, and final-release QC testing in a controlled manufacturing environment. Your role has interface with R&D, Manufacturing, Quality, MSAT and Supply Chain teams.

Also, you are:

Performs data analysis under minimal guidance and communicates these results to the supervisor and coordinating departments. Works closely with technical and operational subject matter experts to understand processes and to perform root cause analysis on data issues.

You may execute validation studies, test protocols under guidance, generate analytical reports, evaluate processes & procedures, utilize statistical techniques, review specifications, and inspect & test equipment.

Participates in departmental projects—work with QC, QA and MSAT on OOS and NCR investigations as needed

Prepares/formulates QC test solutions following SOP/guidelines given by supervisor; solutions include aqueous solutions containing salts, organics, acids, bases and/or modified DNA and organic solutions

Performs laboratory tests on incoming raw materials, in-process samples, and final product samples before distribution as needed following standard operating procedures. Completes batch records while maintaining good documentation practices

Who you are

You hold a B.S. degree as minimally required (basic sciences, life sciences, or engineering) You bring 3 years of relevant experience in a QC capacity. Data analysis experience using JMP, SPSS, SAS, or SQL is highly desirable

Behaviors, competencies, and qualities of the ideal applicant.

Strong analytical skills/problem-solving/conceptual thinking skills. Ability to work in a multi-functional team environment

Technical knowledge of molecular biology and techniques, including principles of nucleic acid hybridization, probe and primer design, enzymatic amplification of specific gene sequences, DNA extraction, PCR Amplification, etc.

Knowledge of safety precautions required for working with biohazards and bloodborne pathogens

Knowledge of basic statistics relevant to the interpretation and analysis of scientific data.

The expected salary range for this position based on the primary location of California is 43,300.00 - 80,300.00 USD annually.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  This position is eligible to earn incentive compensation that is calculated and paid in accordance with the applicable Incentive Compensation Plan for the role. This position also qualifies for the benefits detailed at the link provided below.

Benefits. Relocation benefits are not offered for this position.

 

Who we are

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.  As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses.  GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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