Principal Quality Specialist Pre-Production

As the pioneers of Polymerase Chain Reaction (PCR) technology, Roche Molecular Systems, Inc. has embarked on an incredible adventure that has not only launched the use of reliable DNA-based tests into laboratories worldwide, but has also aided the genetics revolution, which is dramatically altering the future of medical care.  Every day is a new opportunity to create novel diagnostic tools, close the gap on infection and detection, and take the power of genomics to the next level to identify potential diseases before they occur.  It’s an exciting place to be, and the journey has just begun.  We currently seek an experienced professional to join our Pleasanton, California facility.

 

Principal Quality Specialist Pre-Production

 

A Principal Quality Specialist in the Pre-Production Quality Assurance Department performs activities in accordance with internal RMS policy and SOPs. Responsibilities include supporting the Manager/Director and providing design control guidance and independent review of work product (e.g., DHF documents) arising from the design and development of new or revised products (reagents and/or instrument and software systems) that define or demonstrate the quality attributes of products to be distributed by RMS. Key functions include assuring the design control compliance by providing guidance to cross functional product development and life cycle teams, consistent with design control regulations (QSR, ISO and RMS policy and SOPs). Involves reviewing DHF records (plans, protocols, reports) on behalf of Quality Management; preparing Quality Reports assessing compliance at the Design Input, Design Output and Launch Decision milestones; and assisting management in assessing whether these projects/products meet the requirements of these milestones.

 

The successful candidate will have a Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or a related scientific discipline and 2-6 years of related experience (or equivalent combination of education experience). Requires a thorough knowledge of and experience with QSRs in an in-vitro diagnostics environment, and expertise in development and/or design control compliance, coupled with intermediate/advanced knowledge of RMS PCR products and SOPs. Must have a successful track record of participation on cross-functional technical/project teams.

Roche Molecular Systems, the number one diagnostics company on the globe, is a worldwide leader in the development and manufacture of reagents and instruments for early, rapid and accurate disease diagnosis. Located between UC Berkeley and Stanford University in the heart of San Francisco's Biotech Bay, we offer an excellent compensation and benefits program, complete with a matching 401(k), pension plan, 100% tuition reimbursement, flexible hours, credit union, year-end holiday week, periodic company-paid physicals, fitness reimbursement programs and childcare assistance. We are looking for people excited in developing life-saving products, people with a passion to learn and improve; who want to make a real difference in getting patients and doctors the information to diagnose and treat complex diseases. For consideration, please visit our website and apply online, indicating Job Code RMD060135 http://careers.ind.roche.com/joblist.html Principals only, please. We are committed to providing equal opportunity to a diverse workforce.