QA Operations Associate (Weekdays)
Novartis Group Companies, Indianapolis, IN, United States
Job Description Summary
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 lifesaving 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.
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 elevate 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
Bachelor's 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.
Salary Range
55,000.00 – 102,200.00 USD per year, plus performance‑based cash incentive and eligibility for annual equity awards.
Skills Desired
Collaboration
Communication Skills
Data Integrity
Deadline Adherence
Dealing With Ambiguity
Digital saviness
Health & Safety Regulations Knowledge
Leadership
Monitoring
Problem Solving SkillsPunctuality
Regulatory Requirements knowledge
Accessibility and Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e‑mail to us.reasonableaccommodations@novartis.com or call +1(877)395‑2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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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 lifesaving 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.
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 elevate 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
Bachelor's 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.
Salary Range
55,000.00 – 102,200.00 USD per year, plus performance‑based cash incentive and eligibility for annual equity awards.
Skills Desired
Collaboration
Communication Skills
Data Integrity
Deadline Adherence
Dealing With Ambiguity
Digital saviness
Health & Safety Regulations Knowledge
Leadership
Monitoring
Problem Solving SkillsPunctuality
Regulatory Requirements knowledge
Accessibility and Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e‑mail to us.reasonableaccommodations@novartis.com or call +1(877)395‑2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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