Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionQC Specialist (12-hours shift)1) GeneralFunction: Quality ControlReport to: QC Team Leader2) PurposeSupport the Department in the following:Performance of testing to meet quality timelines and necessary trending analysis.Performance of testing in accordance with cGMP regulations and Roche/Genentech standards.Continuous improvement of processes and technology to drive right first time and efficiencies.Ensuring test methods and data are generated in a compliant manner following cGMPs.3) Key ResponsibilitiesTechnical and Functional:Testing and review of routine and non-routine product related samples and in-process samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).Testing, documentation and review of results in accordance with current Good Manufacturing Practices (cGMP) and Procedures.Ensure timely completion of testing and reporting of test results in support of manufacturing operations.General lab support including housekeeping, equipment maintenance, maintaining inventory of lab supplies.Author and/or update existing SOP and TM as needed.Train other analysts on methods and/or SOP.Participate/ support in QC or cross functional projects: equipment qualification, method validation, method transfer, process improvement projects.Support investigation and studies.Problem solving of testing related issues as well as troubleshooting of equipment.Initiator and/or lead for discrepancy and investigation record.Perform assessment for lab related discrepancies and identify corrective actions where necessary.Work closely with network SME and actively participate in cross functional meetings as and when required.Responsible for ensuring that all training required to support/ perform GMP activities are completed timely.Leadership:Work cooperatively with the direct line supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards the team's objectives/goals, take initiative and proactively turn ideas into action - to make things happen.Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.A team player and the willingness to cover other colleagues in continued support of QC operations.Safety, Health & Environment:Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as possible.Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.Lean Production System:Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.4) QualificationsEducation:Degree/Diploma in biology, microbiology, biochemistry, chemistry or other relevant discipline is preferred.1 - 3 years of related working experience for degree holders or equivalent holders with a combination of education and relative work experience.Related working experience in a biotech or pharmaceutical operating environment is preferred.Knowledge/Skills/Competencies:Strong knowledge of analytical, biochemistry and/or microbiology laboratory operations in support of commercial manufacturingKnowledge of cGMP relevant to the pharmaceutical industryKnowledge of laboratory safety proceduresKnowledge of Quality System principles, practices and standards for the pharmaceutical industryDemonstrate excellent verbal and written communication skills in EnglishIndependent, reliable and collaborative team playerRequire to perform night shift if neededWho we areAt Roche, more than 100,000 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.
