Healthcare Businesswomen’s Association
QA Batch Release Specialist
Healthcare Businesswomen’s Association, Indianapolis, Indiana, us, 46262
Job Description 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.
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.
Location: Indianapolis, IN (Onsite)
Shift: Night Shift, weekend nights included
Key Responsibilities
Perform release of all manufactured, packaged, and tested materials including but not limited to 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 expedite any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Ensure specifications are in place and compliant with GMP.
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.
CAPA management and improving 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 a related degree. In lieu of a degree, 5 years in a role within pharma industry that includes quality assurance and batch release experience will be considered.
2+ years of experience in GxP biopharmaceutical manufacturing operations.
1+ year of experience in a quality assurance role.
Cross-functional collaboration.
QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired.
Proven track record and practical experience with cGMP requirements.
Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
Salary and Benefits Salary Range: $81,200 – $150,800 per year. The final salary offered is determined based on factors such as relevant skills and experience. Compensation includes 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. Employees also have a generous time off package including vacation, personal days, holidays, and other leaves.
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 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 email 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.
Preferred Skills
Continued Learning
Dealing With Ambiguity
GMP Procedures
QA (Quality Assurance)
Quality Control (QC) Testing
Quality Standards
Self-Awareness
Technological Expertise
Technological Intelligence
#J-18808-Ljbffr
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.
Location: Indianapolis, IN (Onsite)
Shift: Night Shift, weekend nights included
Key Responsibilities
Perform release of all manufactured, packaged, and tested materials including but not limited to 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 expedite any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Ensure specifications are in place and compliant with GMP.
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.
CAPA management and improving 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 a related degree. In lieu of a degree, 5 years in a role within pharma industry that includes quality assurance and batch release experience will be considered.
2+ years of experience in GxP biopharmaceutical manufacturing operations.
1+ year of experience in a quality assurance role.
Cross-functional collaboration.
QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired.
Proven track record and practical experience with cGMP requirements.
Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
Salary and Benefits Salary Range: $81,200 – $150,800 per year. The final salary offered is determined based on factors such as relevant skills and experience. Compensation includes 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. Employees also have a generous time off package including vacation, personal days, holidays, and other leaves.
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 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 email 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.
Preferred Skills
Continued Learning
Dealing With Ambiguity
GMP Procedures
QA (Quality Assurance)
Quality Control (QC) Testing
Quality Standards
Self-Awareness
Technological Expertise
Technological Intelligence
#J-18808-Ljbffr