Quality Control Specialist I/II

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.

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The following information provides an overview of the skills, qualities, and qualifications needed for this role.

The Position

We're advancing science to ensure everyone has access to the healthcare they need.

The Opportunity

The Quality Control team is looking for two Quality Control Specialists, I and II for the 2nd shift.

Shift : 2nd Shift / Mon-Fri 4 : 30 pm-1 : 00 am, Saturdays may be required during Flu Season.

As a Quality Control Specialist, you will conduct incoming, in-process, and final-release QC testing in a controlled manufacturing environment.

You may also implement validation studies, and test protocols, generate analytical reports, investigate Non-Conformances, evaluate processes & procedures, apply statistical techniques, review specifications, and inspect & test equipment.

You are collaborating with R&D, Manufacturing, Quality, and Supply Chain within the company and when appropriate with customers and suppliers on quality-related issues. Also, you are :

• Preparing / formulating QC test solutions including aqueous solutions containing salts, organics, acids, bases and / or modified DNA and organic solutions
• Performing validation and stability studies, implementing protocols, analyzing data, and initiating non-conformances for MRB
• Completing batch records while maintaining good documentation practices, cGMP, and ISO standards
• Responsible for timely completion of scheduled work orders and monitoring inventory levels
• Participating in departmental projects-works with QC members on OOS / NCR / CAPA investigations as needed

Additional responsibilities for the Quality Control Specialist II :

• Completes batch records while maintaining solid GDP
• Monitors 5S and inventory levels daily
• Performs complex data analysis and communicates these results to the supervisor and coordinating departments.
• Conducts routine and non-routine QC testing following standard operating procedures and guidelines
• Trains new employees on procedures

Who you are

Quality Control Specialist I :

B.S. degree required, in basic sciences, life sciences, or engineering and / or three (3) years of experience in a QC capacity

Quality Control Specialist II :

B.S. degree required, in basic sciences, life sciences, or engineering with five (5+) years of relevant experience in a QC capacity

Preferred

• Technical knowledge of molecular biology, including principles of nucleic acid hybridization, probe and primer design, and enzymatic amplification of specific gene sequences
• Safety precautions required for working with biohazards and bloodborne pathogens knowledge
• Knowledge of the Quality System; able to implement change orders
• Basic statistics relevant to the interpretation and analysis of scientific data. Understanding of molecular techniques (DNA extraction, PCR Amplification)

The expected salary range for the position Quality Control Specialist I, based in California is 43,300 - 80,300 USD annually.

The expected salary range for the position Quality Control Specialist II, based in California is 51,500 - 95,700 USD annually.

Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Relocation benefits are not available for this posting.

Benefits

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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