1+ months

Case Investigation and Resolution (CIR) Principal Scientist

Roche
Pleasanton, CA

For our Case Investigation and Resolution (CIR) department, we are looking for a Principal Scientist, supporting the team for our Blood Screening portfolio of Roche Molecular Diagnostics. In this challenging position, you will be working in a global, matrix environment, supporting virology assays, reagents and applications and interfacing with a variety of departments in handling customer inquiries and complaints.  Additionally, you will assume a leadership role within the Case Investigation & Resolution RMD Reagents Team to resolve complex investigations within our Blood Screening portfolio.  

Responsibilities:

  • Timely handling of customer complaints and inquiries according to regulatory and ISO Quality system requirements and the needs of the Country Organizations, including, evaluating inquiries and complaints based on information obtained from the customer and within business systems, performing and/or coordinating investigations and documenting results for inquiries and complaints related to virology reagents and assays.
  • Experimental design of complaint investigations to ensure an efficient approach for root cause analysis and troubleshooting.
  • Collaborating with key interfaces within the Business Area, Operations, Development and other global functions (as necessary) to ensure actionable resolutions are identified.
  • Initiating and supporting CAPAs originating from complaints until resolutions are implemented.
  • Mentoring and providing support to junior staff on complex investigations.
  • Coordinating knowledge transfer from manufacturer, R&D, etc for new products or product updates to ensure availability of comprehensive product knowledge.

Qualifications:

  • BSc in Life Science or relevant field.
  • 5 to 7 years of experience within the diagnostics, pharmaceutical or medical device industry.
  • Strong analytical skills and hands-on experience investigating product performance issues.
  • Knowledge of US FDA and ISO requirements.
  • Strong analytical skills
  • Excellent written and verbal skills.
  • Strong customer and business orientation
  • Strong communication skills in English (written and spoken)

Preferred:

  • MBA, MSc or PhD in Life Science or relevant field.
  • 8+ years of experience within the diagnostics, pharmaceutical or medical device industry.
  • Advanced knowledge of the diagnostic market
  • Experience in technical writing
  • ASQ or RAPS certification

Roche is an equal opportunity employer.

Research & Development, Research & Development > Research
Posted: 2018-09-07 Expires: 2018-11-08

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Case Investigation and Resolution (CIR) Principal Scientist

Roche
Pleasanton, CA

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