Scientist, Case Investigation and Resolution at Roche

Application Details:
To apply for the position please submit the following in a single word or PDF file:

• Letter of motivation (one A4 page max.)
• Curriculum vitae, highlight only relevant qualifications and experience as it pertains to the job description. Include the email addresses and daytime phone numbers of at least 3 referees.

Job Description Summary
The Case Investigation and Resolution department is the Center of Excellence for the resolution of global product complaints. The Scientist (CIR) is responsible for effective and timely resolution of global cases, including complaint investigations, risk assessments, case documentation, trending analysis and preparing reports, and ensuring regulatory compliance and optimal levels of customer satisfaction. The ideal candidate has strong technical knowledge, expertise of assay workflow and system functionality, enjoys troubleshooting, and has a problem solving mindset.
This will be a 12-month contract.
 

2.1.Role and Responsibilities

• Accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements and regulations, and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site trouble-shooting and resolution of cases.
• Responsible for experimental design of complaint investigations, conducts investigation experiments, and analyzes data using statistical measures for determining a potential product performance issue.
• 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, in a timely manner.
• Initiates, monitors and ensures completion of complaint CAPAs and triggers appropriate preventive actions resulting from complaints.
• Provides information from cases in order to update product documentation.
• Assumes responsibility for timely communication of quality related information to the Country Organizations.
• Assumes responsibility for regular peer review of escalated cases.
• Supports initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.
• Provides audit and inspection support as requested.
• Contributes to the creation of regular reports to document on-market product quality and performance, to escalate critical issues to the responsible Life Cycle Teams and to define pro-active measures.
• Contributes to case-related trending to understand the scope of an issue.
• Supports 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 a focus on customer, compliance and continuous improvement.
• Assumes responsibility to ensure risk assessments for product quality issues are complete.
• The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. May be required to perform other duties as assigned to meet the CIR goals and objectives as appropriate.
   

Qualifications And Experience Requirements
Required:

• Bachelors degree in life sciences, engineering or related field, or equivalent combination of education and work-related experience.
• Proficient in technical writing
• Background in Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry or related sciences.
• Solid communication skills (written and spoken) in English are essential.

Preferred:

• Work experience in technical product support role, research and development setting, technical customer support role or related function.
• Experience with Molecular Biology techniques, including PCR technology.
• Problem solving and troubleshooting capabilities.
• Root Cause analysis knowledge.
• Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485).
• Experience working with global cross functional teams.
• Computer literate, with knowledge of e-learning, multimedia technologies.
• Demonstrated analytical, solutions oriented and collaborative approach to problem solving.
• Very good presentation and communication skills.
• Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner.
• Customer advocate and business orientation.
• Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).

Additional Notes
The position requires an individual with strong organizational and attention to detail skills. They must have initiative and be self-motivated to achieve. They must be able to work with a diverse team of managers and scientists. Other desirable attributes include accountability, flexibility and strong work ethic.