Quality Assurance Specialist

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

At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

As a Quality Assurance Specialist at Roche, you are responsible for supporting the quality oversight activities required for the day-to-day operations for the Roche owned and operated clinical laboratories. Laboratory quality assurance plays a crucial role in ensuring that trial data is reliable and accurate, which in turn supports scientific discovery and facilitates access to new drugs and medical devices. This position works closely with each Quality Site Lead to ensure study/process quality and organizational efficiency.

The Opportunity 

• You assist in the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with CLIA, ISO 15189, GCP, and state regulations.

• You monitor and document non-conformances, assist in root cause analysis, and support the implementation of corrective and preventive actions (CAPA).

• You support the preparation of laboratories for external audits and inspections by regulatory bodies, accreditation organizations, and customers.

• You track and trend quality metrics, and present these metrics as part of management review meetings.

• You ensure appropriate licenses are maintained with government agencies to allow uninterrupted laboratory operations

• You aid in the development and review of standard operating procedures (SOPs) and other controlled documents. You coordinate and deliver education for lab staff on applicable standards, guidelines and best practices.

• You support lab personnel in meeting continuous education, competency, and proficiency requirements and assist in the investigation and resolution of quality issues and customer complaints related to laboratory operations.

• You collaborate with cross-functional teams to promote a culture of continuous improvement within the laboratory.

Who You Are

• You have a Bachelors Degree in Life Sciences, Medical Technology, Quality Assurance or a related field

• You have at least 1-5 years of experience in the Medical Device/Pharmaceutical Industry, preferably with IVDs.

• Previous experience with clinical studies and/or clinical laboratory operation is preferred.

• Knowledge of quality management systems and good documentation practices is preferred.

Knowledge, Skills and Abilities

• You have excellent attention to detail and organization skills

• You have strong analytical and problem-solving abilities

• You hold effective communication and interpersonal skills to work collaboratively with various teams

• You are proficient in using Google (Docs, Sheets, Slides) and/or Microsoft Office (Word, Excel, Powerpoint) Suites

• You have the ability to handle multiple priorities and meet deadlines in a fast-paced environment

• You have a strong commitment to quality and continuous improvement.

Locations

 You are located in Tucson, Arizona or San Jose, California. 

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Arizona is $82,600 and $153,000.  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.

Benefits 

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

Roche 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.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.