Clinical Process Excellence Specialist

Pleasanton, CA 94588

Posted: 11/22/2019 Employment Type: Contract Industry: Quality & Regulatory Affairs Job Number: 7200

Job Description


Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

 

Duties:
  • Supports the Head of Clinical Process Excellence in process and continuous improvement, harmonization, regulatory compliance, training, and inspection readiness activities across COBM.
  • Provides logistical and technical support and expertise for audits and inspections involving COBM.
  • Reviews study documentation to help ensure compliance with standard operating procedures and applicable regulations.
  • Collaborates with key stakeholders and acts as a change agent in support of the process improvement activities across COBM.
  • Performs quality checks on work executed on behalf of Log-In; for example: training material, deployments of training, role-based training matrices, metrics reporting, and communications.
  • Contributes to innovative sustainable solutions in support of establishing a standardized approach and oversight of best practices.
  • Perform needs assessments and track trends to support the quality continuous improvement strategy.
  • Provides assistance with training programs across required geographic locations and applicable technologies, including, but not limited to assistance with: training material, trainer and trainee schedules, event logistics, delivering trainings, documentation, and feedback, as applicable.
  • Other duties as assigned by manager.

 

Job Requirements

Skills:

  • Working knowledge of Quality and best practices.
  • Attention to detail and a process
  • Strong results orientation and change
  • Strong stakeholder management
  • Excellent communication, facilitation and interpersonal skills
  • Ability to achieve results in a quality or operational
  • Knowledge / expertise in the science and technical aspects of applicable Roche instruments and assays

 

Education:

  • BS/BA in technical/scientific field or technical experience
  • At least 2 years of relevant experience in Clinical Operations, Biometrics, Quality, or related field
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