Quality Assurance Specialist

4 days ago


Marquand, Missouri, United States Novartis Group Companies Full time

At the Novartis Group Companies, we are committed to leading innovation in nuclear medicine and delivering targeted radioligand therapy to cancer patients.

We are seeking an experienced Quality Assurance professional to manage quality aspects and projects within their area of responsibility, ensuring overall GxP conformity and Compliance with our Quality Management Systems.

The successful candidate will be responsible for:

  • Providing shopfloor quality oversight of production, quality control, and supply chain departments to ensure adherence to cGMP, including data integrity;
  • Performing live review of manufacturing batch records and escalating discrepancies immediately;
  • Assisting functional areas with achieving timely and compliant final product disposition;
  • Reviewing, approving, and supporting procedures and production/testing records as required;
  • Ensuring compliance of site personnel and application of aseptic techniques and sterile manufacturing regulations;
  • Supporting FDA/Regulatory interactions for the Indianapolis site activities and products;
  • Collaborating with cross-functional teams to drive quality and safety initiatives;

This role offers a unique opportunity to work in a fast-paced environment, driving quality and compliance initiatives that impact patient care.

We offer a competitive salary range of $88,000.00 - $132,000.00, commensurate with experience and qualifications.

Please note that this role requires 2+ years of experience in a GxP Biopharmaceutical manufacturing operations and 1+ years of experience in a quality assurance role.



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