Application Scientist CIR

Job description

  Job facts

Within Case Monitoring and Resolution (CMR), the Case Investigation & Resolution (CIR) Applications Scientist is accountable for the following key responsibilities:

Essential Job Functions and Major Contributions:

·  Assumes accountability for the management of individual cases [Inquiries, Complaints, Potentially Reportable Incidents (PRI)/Potential Safety Issues (PSIs)] stemming from the end-user according to regulatory and ISO Quality system requirements and needs of the Country Organizations. This includes creation, acceptance, classification, investigation, complete documentation, on-site troubleshooting and resolution of cases, in a timely manner.
·  Contributes to experimental design of investigations to ensure an efficient approach for root cause analysis.
·  Perform risk assessments of process or product non-conformances.
·  Ensures, by collaboration and interfacing with Business Area and global functions, appropriate measures from cases are derived, including, but not limited to workarounds.
·  Assumes responsibility for timely communication of quality related information to the Country Organizations.
·  Assumes responsibility for providing information from cases in order to update product documentation.
·  Contributes to initial and continuous knowledge transfer from manufacturer, Research & Development (R&D) or Global Customer Support (GCS) for new products in the project phase to ensure availability of comprehensive system knowledge.
·  Supports initiatives and measures to maintain enhanced interface with Country Organizations and regional representatives.
·  Supports creation of regular reports to document in-market product quality and performance.
·  Optimizes processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement.

Other Tasks, Duties and Responsibilities

·  Creates “notifications” (Bulletins and communications to affiliates and ultimately customers via the local organizations) and contributes to creation of reports (any type of trending or Key Performance Indicators (KPIs) reporting, on product or process performance) generally used by the department to report progress or to be presented to interfacing areas (e.g. Business Area, Life Cycle Teams, International Business Team, Global functions).
·  May 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.

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:

·  Bachelor’s degree in Life Sciences or higher (molecular biology, genomics, genetics, sequencing, biology, medical technology or similar) or related technical discipline (engineering, bioinformatics) or equivalent professional experience.
·  Proven strong interpersonal skills with an analytical, solutions oriented, collaborative approach to problem solving
·  Technical knowledge of next-generation sequencing, genomics, molecular biology, or related technologies and applications.
·  Prior work experience in either 1st or 2nd level product support, in the area of medical technology or R&D/QC related functions desirable.
·  Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g. 21CFR 820,198, ISO 9001, ISO 13485, etc.). Complaint handling experience desirable.

Other Qualifications & Competencies:

·  Experience with Linux is desirable.
·  Experience with short read NGS data, including common data analysis software (eg. bwa, samtools, GATK, Varscan etc.), variant detection algorithms, variant annotation and QC metrics preferred.
·  Strong communication skills in English (written and spoken) are essential. Knowledge of additional languages is a plus.
·  Proven strong interpersonal skills with an analytical, solutions oriented, collaborative approach to problem solving, troubleshooting capabilities and negotiation attitude.
·  Sound technical product knowledge and principle of operation for the product’s intended use, customer workflow and technical knowledge of assay and system functionality.
·  Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).
·  Computer literate, knowledge of e-learning and multimedia technologies.
·  Very good presentation and communication skills. Experience in technical writing.
·  Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner.
·  Strong customer focus and business orientation. Intercultural skills.
·  Travel requirements of approximately up to 25%.

Roche is an equal opportunity employer.
Research & Development, Research & Development > Research

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

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.