Principal Scientist I, Design Quality

  • Roche
  • Pleasanton, CA, USA
  • May 05, 2021
Biotech QA-Quality Control Science

Job Description

Impact Healthcare

Roche Molecular, one of four customer-focused areas of Roche Diagnostics Solutions, develops, manufactures and supplies a wide array of innovative molecular diagnostic products, tests, platforms and technologies used to identify and quantify DNA and RNA from different organisms. We are transforming testing and treatment together. As pioneers of polymerase chain reaction (PCR) technology, scientific and clinical excellence is in our DNA. Our leadership and continued advancement of the technique enables PCR to make real differences in the lives of patients, laboratories and healthcare professionals everywhere.

Make a Big Difference

Do you have a knack for process improvement while having a solid Design Control background? As a Principal Scientist I, Design Quality Assurance (DQA), you will provide support and guidance to product development teams on Design Control, Compliance to Regulations, Product Launch, etc., while improving Quality Systems/Processes. You are essentially the Design Quality Engineer working closely with Product Development teams.

Responsibilities:
  • Provide Design Control guidance to product development under direction from Life Cycle Teams (LCT). Act as the single point representative for all Quality Management System activities for Project Teams.
  • Review and approve documentation consistent with design control regulations and guidance, Roche Diagnostic Divisional Standards and business area/unit specific processes and procedures. Documentation includes, but is not limited to, design control-related documents such as design development plans, risk management plans/reports, customer requirements, product requirements, technical performance verification protocols/reports, clinical study plans/reports, design transfer documents, labeling, and milestone documentation.
  • Communicate critical product quality or compliance-related issues to Quality Management to ensure alignment with Quality policy and objectives. Participate in difficult discussions, challenge the status quo, and identify mutually beneficial compliant solutions with cross-functional colleagues at the Project Team level. Work closely and partner with DQA colleagues within and across sites to ensure consistent application of design control-related processes.
  • Author Quality Reports. Advise and support Project Teams during the planning of milestones to complete required deliverables. Assist management in assessment of whether the project has met requirements to pass milestone.
  • Provide feedback on new or revised SOP's associated with design control activities/compliance. May be the key contributor/coordinator for Quality feedback on SOP revisions working closely with the respective SOP owner and DQA leadership.
  • Support internal and external audits/inspections. May Proxy for QFL as requested for LCT. Activities may include nonconformance review and approval, and document change review and approval within Trackwise. Activities may include equipment installation qualification review and approval.


Who You Are

When you join us, you will have meaningful work developing an innovative technology that saves and improves lives around the world. As you collaborate with some of the best in the industry, you will make a huge difference in disease diagnostics! Our team is collaborative and fast-paced. And, we offer a competitive salary with a rich benefits package.

Requirements:
  • Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related discipline. Master's degree is preferred. Or, equivalent combination of education and work-related experience.
  • A minimum of 5+ years of experience under established quality regulations, including intermediate knowledge of medical device or pharma processes; 8+ years of experience working under established quality regulations with knowledge of in-vitro diagnostic products including nucleic acid based products is preferred.
  • Strong track record of successful participation on cross-functional teams.
  • Working knowledge of QSR/cGMP, ISO and Design Controls.
  • Excellent oral, written and interpersonal communication skills.


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 connection with the on-line application process, please email us at US.Accommodation@roche.com .

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