Novartis
Radioligand Therapies
QAOperationsAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“QA Operations Associate at Novartis. Skills: shopfloor quality support, GMP compliance, data integrity, continuous quality improvement. Provide active shopfloor quality support across production, quality control, and supply chain operations to ensure adherence to current Good Manufacturing Practices and data integrity standards.. Support daily manufacturing operations through hands‑on quality programs such as visual monitoring, area release activities, and equipment, area, or utility status mana”
What You'll Achieve.
ensure the highest GMP standards are met; precision oncology therapies reach patients safely and on time; strengthen right‑first‑time execution
Industry & Context.
What They're Looking For.
Must Have
At least two years of experience in GxP pharmaceutical or API manufacturing operations., Demonstrated knowledge of Good Manufacturing Practice compliance and data integrity expectations., Experience supporting environmental monitoring programs and classified manufacturing areas., ability to collaborate across cross-functional manufacturing and support teams.
Nice to Have
Experience supporting quality operations in a nuclear medicine or radiopharmaceutical manufacturing environment., One year of experience in a quality assurance role and/or previous experience with deviations and change control records is preferred.
What You'll Do.
Provide active shopfloor quality support across production
and supply chain operations to ensure adherence to current Good Manufacturing Practices and data integrity standards.
Support daily manufacturing operations through hands‑on quality programs such as visual monitoring
area release activities
or utility status management.
Partner with manufacturing teams to ensure approved procedures and Good Manufacturing Practice requirements are consistently followed during routine operations.
Support compliant raw material disposition by working directly with functional teams to resolve issues efficiently and in alignment with quality standards.
Perform material release.
Oversee final product storage activities following completion of manufacturing
ensuring controlled conditions and compliance with site quality requirements.
Review facility alarms and operational events
assess potential Good Practice impact
and promptly escalate quality risks to appropriate stakeholders.
Contribute to continuous quality improvement initiatives by collaborating with production
and supply chain teams to strengthen right‑first‑time execution.
How You'll Work.
Team & Collaboration
partnering with the shop floor; Partner with manufacturing teams; working directly with functional teams; collaborating with production, engineering, and supply chain teams; collaborate across cross-functional manufacturing and support teams
Full Job Description
**Band** Level 2 **Job Description Summary** #LI-Onsite Location: Indianapolis, Indiana Relocation Support: This role is based in Indianapolis, Indiana. Novartis is unable to offer relocation support: please only apply if accessible. Quality can be the difference between waiting and receiving life‑saving treatment. As a QA Operations Associate supporting Novartis’ Radioligand Therapies, you’ll be hands‑on partnering with the shop floor to ensure the highest GMP standards are met so precision oncology therapies reach patients safely and on time. Every decision you make directly supports people battling cancer and helps deliver treatments when they matter most. NOTE: This role will support our new Isotopes Manufacturing facility. Shift hours and schedule will evolve as we move from start up to business as usual. We anticipate the Weekday Day shift will work Monday - Thursday. Shifts may be 10 or 12 hours per day. **Job Description** **Key Responsibilities** * Provide active shopfloor quality support across production, quality control, and supply chain operations to ensure adherence to current Good Manufacturing Practices and data integrity standards. * Support daily manufacturing operations through hands‑on quality programs such as visual monitoring, area release activities, and equipment, area, or utility status management. * Partner with manufacturing teams to ensure approved procedures and Good Manufacturing Practice requirements are consistently followed during routine operations. * Support compliant raw material disposition by working directly with functional teams to resolve issues efficiently and in alignment with quality standards. Perform material release. * Oversee final product storage activities following completion of manufacturing, ensuring controlled conditions and compliance with site quality requirements. * Review facility alarms and operational events, assess potential Good Practice impact, and promptly escalate quality risks to appropriate stakehold
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