QA Operations Associate (Weekdays)
Novartis Pharma Schweiz, Indianapolis, IN, United States
Overview
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.
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 stakeholders.
Contribute to continuous quality improvement initiatives by collaborating with production, engineering, and supply chain teams to strengthen right‑first‑time execution.
Essential Requirements
Bachelors' Degree, preferably in Life Sciences, Chemistry or related relevant degree preferred. In lieu of degree, 3-5 years in a role within pharma industry that includes quality assurance experience will be considered. 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.
Strong ability to collaborate across cross-functional manufacturing and support teams.
Desirable Requirements
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.
The salary for this position is expected to range between $55,000 and $102,200 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
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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.
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 stakeholders.
Contribute to continuous quality improvement initiatives by collaborating with production, engineering, and supply chain teams to strengthen right‑first‑time execution.
Essential Requirements
Bachelors' Degree, preferably in Life Sciences, Chemistry or related relevant degree preferred. In lieu of degree, 3-5 years in a role within pharma industry that includes quality assurance experience will be considered. 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.
Strong ability to collaborate across cross-functional manufacturing and support teams.
Desirable Requirements
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.
The salary for this position is expected to range between $55,000 and $102,200 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
#J-18808-Ljbffr