Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Pleasanton

Description

Within Case Monitoring and Resolution (CMR), the Case Investigation & Resolution (CIR) Senior Scientist is accountable for the following key responsibilities.
The ideal candidate has strong technical knowledge, expertise of assay workflow and system functionality, enjoys troubleshooting, and has a problem solving mindset with a focus on customer satisfaction.
Essential Job Functions and Major Contributions:
Assumes accountability for the management of individual cases (Inquiries, Complaints, PRI/PSIs) according to regulatory and ISO Quality system requirements and the needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site troubleshooting and resolution of cases, in a timely manner. Cases need to be auditable and well documented to be self-explanatory to a person who has no specialized product or process knowledge (e.g. in an audit).
Is responsible for experimental design of investigations of complaints to ensure an efficient approach for root cause analysis. Performs/assists in complex investigations by proactively identifying and collaborating with appropriate functions to identify root causes, plausible factors workarounds.
Scientific documentation of investigations. Where appropriate including (but not limited to) test plan, proof of statistical relevance, documentation of methodology, conclusion and traceability of an investigation.
Assumes responsibility to ensure, by collaborating and interfacing with the BA and global functions, appropriate measures from cases are derived, including, but not limited to workarounds.
Initiates, monitors and ensures completion of complaint CAPAs and triggers appropriate preventive actions resulting from cases.
Initiates and monitors the implementation of product documentation updates, modifications and developments resulting from cases, influencing the future of products in the field.
Assumes responsibility for timely communication of quality related information to the Country Organizations. Supports initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.
Assumes responsibility for regular review of escalated cases. Contributes to constant evaluation of global case resolution vs. regional and local practice.
Is responsible for initial and continuous knowledge transfer from manufacturer, R&D or GCS for new products in the project phase to ensure availability of comprehensive system knowledge.
Contributes to creation of regular reports to document in-market product quality and performance, to escalate critical issues to the responsible LCT and to define pro-active measures.
Contributes to case-related trending to understand scope of an issue.
Performs regular review of quality of case handling, CAPA management and analyzes feedback on customer satisfaction to permanently optimize processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement.
Provides regulatory inspection support.
Assumes accountability for mentoring new employees and team members.
Other Tasks, Duties and Responsibilities
Creates Affiliate Notifications (communications to affiliates and ultimately customers via the local organizations) and contributes to creation of reports (any type of trending or KPI reporting, on product or process performance) generally used by the department to report progress or to be presented to interfacing areas (e.g.  BA, LCTs, IBT, Global functions).
Could contribute in task forces for individual case/issue in their area of competency, including representation and communication of individual case/issue results in interfacing meetings.
Analysis and completion of risk assessments resulting from differing failure modes.
Performs / assists in on-boarding of new employees.
Could act as proxy for Principals (empowered to take decisions).
For All Employees:
Permanently optimize processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement, by supporting regular review of quality of case handling, CAPA management and by analyzing feedback on customer satisfaction.
Education and Experience:
University degree in Life Sciences (Molecular Biology, Genomics, Genetics, NextGen Sequencing, Biology, medical technology or similar) and related technical discipline (bioinformatics) or equivalent professional experience is required.
Three (3) or more years of work

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

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