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The Quality Control Analyst is responsible for Quality Control Chemical and Microbiological testing of Product and Raw Materials/packaging components as well operation/maintenance of analytical instrumentation in accordance with Good Manufacturing Practice (GMP) / Food and Drug Administration (FDA) regulations, Advanced Accelerator Applications (AAA) standard operating procedures and Policies. Due to the nature of the process (radioactive) this role requires moderate proficiency, of the basic quality control techniques, analytical instrumentation, sterility principles, and understanding of radiation safety standards.

Your responsibilities include, but are not limited to:

• Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting.
• Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner.
• Support and track the implementation and maintenance of the local Quality system in in
accordance with the Novartis Quality Manual
• Manages processes and systems for all Good Regulatory Practice (GxP) Quality Assurance e.g., Change control, Training Management, Escalation Management, Risk Management. Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality.
• Contributes to an improvement of current processes and/or to an implementation of modified
processes.
• Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), including escalation of issues related to the closure of CAPA, as appropriate.
• Reviews quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments.
• Prepares and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation Supports Compliance review of projects and inspection readiness and management.

The pay range for this position at commencement of employment is expected to be between $84,000 and $126,000 year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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