Novartis ACC
QA Batch Release Specialist – Novartis ACC
Location: Indianapolis, IN
Shift: Night Shift, including weekend nights
Summary Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we’re pioneering the future of treatment through the fusion of nuclear medicine and precision oncology.
About the Role The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance with current GMP regulations, procedures and quality systems.
Key Responsibilities
Perform release of all manufactured, packaged and tested materials including raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
Controlled issuance of batch records in preparation for manufacturing.
Perform review of manufacturing batch records in preparation for batch release and immediately elevate any discrepancies.
Assist functional areas with achieving timely and compliant final product disposition.
Ensure specifications are in place and within GMP compliance.
Support metric tracking of documentation and release data to ensure continuous improvement.
Support QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
Manage CAPA and improve processes within QA Batch release.
Organize and file all executed and associated GMP documentation (e.g., batch records).
Maintain batch documentation library (record check‑in, check‑out, follow‑up, and distribution).
Essential Requirements
Bachelor’s Degree preferably in Life Sciences, chemistry, or related field. In lieu of a degree, 5 years of experience in a pharma industry role within quality assurance and batch release will be considered.
2+ years of experience in GxP Biopharmaceutical manufacturing operations.
1+ year of experience in a quality assurance role.
Cross‑functional collaboration skills.
QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones desired.
Proven track record and practical experience with cGMP requirements.
Knowledge of FDA and EU regulations and experience in international regulatory agency inspections.
Compensation Salary: approximately $81,200 – $150,800 per year (based on relevant skills and experience). Performance‑based cash incentive and eligibility for annual equity awards, subject to review.
Benefits US‑based employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and other benefits. There is a generous time‑off package with vacation, personal days, holidays, and other leaves.
Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. We collaborate, support, and inspire each other, combining to achieve breakthroughs that change patients’ lives.
Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.
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.
Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform essential functions of a position, please email reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and contact information. Please include the job requisition number in your message.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industry Pharmaceutical Manufacturing
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Shift: Night Shift, including weekend nights
Summary Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we’re pioneering the future of treatment through the fusion of nuclear medicine and precision oncology.
About the Role The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance with current GMP regulations, procedures and quality systems.
Key Responsibilities
Perform release of all manufactured, packaged and tested materials including raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
Controlled issuance of batch records in preparation for manufacturing.
Perform review of manufacturing batch records in preparation for batch release and immediately elevate any discrepancies.
Assist functional areas with achieving timely and compliant final product disposition.
Ensure specifications are in place and within GMP compliance.
Support metric tracking of documentation and release data to ensure continuous improvement.
Support QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
Manage CAPA and improve processes within QA Batch release.
Organize and file all executed and associated GMP documentation (e.g., batch records).
Maintain batch documentation library (record check‑in, check‑out, follow‑up, and distribution).
Essential Requirements
Bachelor’s Degree preferably in Life Sciences, chemistry, or related field. In lieu of a degree, 5 years of experience in a pharma industry role within quality assurance and batch release will be considered.
2+ years of experience in GxP Biopharmaceutical manufacturing operations.
1+ year of experience in a quality assurance role.
Cross‑functional collaboration skills.
QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones desired.
Proven track record and practical experience with cGMP requirements.
Knowledge of FDA and EU regulations and experience in international regulatory agency inspections.
Compensation Salary: approximately $81,200 – $150,800 per year (based on relevant skills and experience). Performance‑based cash incentive and eligibility for annual equity awards, subject to review.
Benefits US‑based employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and other benefits. There is a generous time‑off package with vacation, personal days, holidays, and other leaves.
Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. We collaborate, support, and inspire each other, combining to achieve breakthroughs that change patients’ lives.
Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.
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.
Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform essential functions of a position, please email reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and contact information. Please include the job requisition number in your message.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industry Pharmaceutical Manufacturing
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