Senior Analyst, Microbiology and EM Lab, Biologics

Job description

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 Position Principle Roles & Responsibilities / Accountabilities 主要职责/责任 Routine Operation: Perform the microbiological testing on the samples from incoming raw materials and packaging materials, produced bulks and products, environment monitoring, process validation and cleaning validation, etc. Issue the reliable analytical report in reasonable lead time. Adhere to all effective SOPs and safety requirements and document laboratory work consistent with cGMP requirements Assist Head of Microbiology lab to complete GMP Self-Inspection as well as the relevant CAPAs to maintain the global level of GMP compliance. Presents technical analytical data clearly and concisely data to internal investigations and regulatory inspectors. Accomplish the calibration and maintenance of assigned instruments, to ensure they are in good order to meet the analytical needs any time. Report the abnormal status, unexpected results to supervisors with initiative. ● By reporting abnormal status and unexpected results during analysis processing by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time. Maintain laboratory cleanliness and inventory of microbiology supplies Supports lean initiatives in the area of lab operations, test method execution, documentation updates and equipment qualification Engineering Project Support and Operation Readiness: CCS Support: Support the establishment of the Contamination Control Strategy (CCS) for the aseptic production line. Environmental Monitoring (EM): Support EMPQ execution according to the project timeline. Microbiology Method Validation: Support the microbiology methods transfer, including supporting the confirmation of cleaning and disinfection processes, and the efficacy of disinfectants. Equipment Support: Support the Performance Qualification (PQ) of laboratory equipment and ensure routine operation. Qualification and Experience 能力与经验 Education/Qualifications ● Bachelor’s Degree (Life Sciences, Microbiology, or Analytical Sciences is preferred) and above Job Required Competencies ● 2 or more years of QC experience, QC experience, with a focus on microbiology and aseptic processes. MNC Bio-pharma experience is preferred ● Sound knowledge of quality control procedures and legal standards, with experience in aseptic assurance and microbiological testing. ● Experienced in QC new facility startup readiness and operation ramp up is preferred. ● Fluent communications skills in English ● Project management skills are preferred. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.