QA Operations Associate (Weekdays)

Novartis • Indianapolis, IN

1d • Onsite

About The Position

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. This role will support a new Isotopes Manufacturing facility. Shift hours and schedule will evolve as the facility moves from start up to business as usual. The Weekday Day shift is anticipated to work Monday - Thursday, with shifts potentially being 10 or 12 hours per day.

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.

Nice To Haves

• 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.

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.

Benefits

• comprehensive benefits package that includes health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves
• performance-based cash incentive
• eligibility to be considered for annual equity awards

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees