Scientist PMQ

Roche•Carlsbad, CA

4d•Onsite

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Post Market Quality Case Handling and Affiliate Support department is the Center of Excellence for the resolution of global product complaints. The Scientist is responsible for effective and timely resolution of global cases, including complaint investigations, risk assessments, case documentation, trending analysis and preparing reports, ensuring regulatory compliance and optimal levels of customer satisfaction. Also participates in the On-Boarding of new employees by providing product and process training and support. The ideal candidate has strong technical knowledge, expertise of assay workflow and system functionality, enjoys troubleshooting, and has a problem solving mindset. The Opportunity You are responsible for handling complaints specific to the GenMark portfolio and are accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements, regulations, and the needs of Country Organizations, including creation, acceptance, classification, investigation, complete documentation, on-site troubleshooting, and resolution. You are responsible for experimental design of complaint investigations, conducting investigation experiments, and analyzing data using statistical measures for determining a potential product performance issue. You assume responsibility to ensure, by collaborating and interfacing with the BA and global functions, that appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner. You initiate, monitor, and ensure completion of complaint CAPAs and trigger appropriate preventive actions resulting from complaints. You provide information from cases in order to update product documentation. You assume responsibility for timely communication of quality-related information to the Country Organizations and for regular peer review of escalated cases. You support initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives while providing audit and inspection support as requested. You contribute to the creation of regular reports to document on-market product quality and performance, escalate critical issues to the responsible Life Cycle Teams, define proactive measures, and perform case-related trending to understand the scope of an issue. You support regular review of quality of case handling and CAPA management, analyzing feedback on customer satisfaction to permanently optimize processes with a focus on customer, compliance, and continuous improvement. You assume responsibility to ensure risk assessments for product quality issues are complete and may be responsible for training and mentoring new employees and other team members.

Requirements

Bachelor’s degree in Life Science, Engineering, or a Related Field
2+ years of related work experience in a technical product support role, research and development setting, technical customer support role, or related function
Proficient in technical writing
Root Cause analysis knowledge
Computer literate, with knowledge of e-learning and multimedia technologies
Demonstrated analytical, solutions-oriented, and collaborative approach to problem solving, with attention to details, technical orientation, excellent organization skills, solid troubleshooting capabilities, and a negotiation attitude
Knowledge of regulations and IVD standards, and Good Manufacturing Practices (GMP)
Experience working with global cross-functional teams, or similar
Possess solid communication skills (written and spoken) in English, which are essential
Very good presentation and communication skills
Exhibit genuine empathy, patience, flexibility, and the ability to skillfully direct contacts to resolve issues in a timely manner
Possess problem solving and troubleshooting capabilities
Customer advocate with a business orientation

Nice To Haves

Background in Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry, or a related field
Experience with Molecular Biology techniques including PCR technology
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)
Knowledge of additional languages a plus

Responsibilities

Handling complaints specific to the GenMark portfolio and are accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements, regulations, and the needs of Country Organizations, including creation, acceptance, classification, investigation, complete documentation, on-site troubleshooting, and resolution.
Responsible for experimental design of complaint investigations, conducting investigation experiments, and analyzing data using statistical measures for determining a potential product performance issue.
Assume responsibility to ensure, by collaborating and interfacing with the BA and global functions, that appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner.
Initiate, monitor, and ensure completion of complaint CAPAs and trigger appropriate preventive actions resulting from complaints.
Provide information from cases in order to update product documentation.
Assume responsibility for timely communication of quality-related information to the Country Organizations and for regular peer review of escalated cases.
Support initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives while providing audit and inspection support as requested.
Contribute to the creation of regular reports to document on-market product quality and performance, escalate critical issues to the responsible Life Cycle Teams, define proactive measures, and perform case-related trending to understand the scope of an issue.
Support regular review of quality of case handling and CAPA management, analyzing feedback on customer satisfaction to permanently optimize processes with a focus on customer, compliance, and continuous improvement.
Assume responsibility to ensure risk assessments for product quality issues are complete and may be responsible for training and mentoring new employees and other team members.