At Novartis, we aim to change the practice of medicine, and innovation not only means developing effective, targeted medicines quickly, but also ensuring that these medicines get to the patients who need them. Our vision is to be a trusted leader in changing the practice of medicine. To achieve that, we are continuously seeking talented individuals who are passionate about making a difference in healthcare to be a part our team!
We are currently looking for a Senior Quality Control Associate - Chemist for our San Carlos, CA site.
The Senior Quality Control Associate – Chemist will be a key member of our Quality Control Team. This person will provide technical expertise on analytical testing to include in-process, product release, and stability testing on finished products and APIs, troubleshooting test method validations, and data trending. Additionally, this person will provide coaching and mentoring to staff members while promoting continuous improvements within the lab.
• Conduct analytical testing on products and APIs following established SOPs and GMP requirements using HPLC and other analytical instruments.
• Review and approve analytical test results for product release and Stability studies.
• Troubleshoot and investigate any routine and non-routine technical problems.
• Participate in method validation, transfer process, and equipment validation.
• Prioritize, schedule, and allocate resources appropriately to ensure efficient workflow, meet production schedules, and full synchronization with our Process Unit (PU) group.
• Provide training and mentoring to other associates on analytical methods, lab instrumentation operation and troubleshooting, etc.
• Act as a lead investigator on laboratory deviations and outside-of-specification results.
• Lead and drive QC process improvement projects.
• Generate, maintain, and revise test monographs, SOPs, analytical methods and specifications to ensure compliance with regulatory requirements and filings.
• Perform QC analytical data trending and analysis using Minitab or similar tools to calculate continuous process verification (CPV) limits.
• Author stability reports and other technical writing requests.
• Ensure compliance with GMP/HSE regulations, Novartis policies, procedures and standards appropriate for this role.
• Champion a Quality Culture and help ensure a safe working environment.