Novartis Pharma Schweiz
Quality Assurance(QA) Operations Specialist
Novartis Pharma Schweiz, Indianapolis, Indiana, us, 46262
Quality Assurance(QA) Operations Specialist
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.
Location: Indianapolis, Day Shift (Weekends). 2 positions available.
Key Responsibilities
Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity.
Ensure timely escalation to management of all applicable incidents.
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Review, approve and support procedures and production/testing records as required and assist in the training of site associates.
Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
Other related duties as assigned.
Essential Requirements
Bachelor’s Degree, preferably in Life Sciences, chemistry, or related relevant degree.
In lieu of degree, 3‑5 years in a role within pharma industry that includes quality assurance experience will be considered.
2+ years of experience in a GxP Biopharmaceutical manufacturing operations.
1+ years 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.
The salary for this position is expected to range between $81,200 and $150,800 per year. The final salary offered is determined based on factors such as relevant skills and experience, and upon joining Novartis it 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. Employees are also eligible for a generous time‑off package including vacation, personal days, holidays and other leaves.
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Location: Indianapolis, Day Shift (Weekends). 2 positions available.
Key Responsibilities
Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity.
Ensure timely escalation to management of all applicable incidents.
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Review, approve and support procedures and production/testing records as required and assist in the training of site associates.
Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
Other related duties as assigned.
Essential Requirements
Bachelor’s Degree, preferably in Life Sciences, chemistry, or related relevant degree.
In lieu of degree, 3‑5 years in a role within pharma industry that includes quality assurance experience will be considered.
2+ years of experience in a GxP Biopharmaceutical manufacturing operations.
1+ years 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.
The salary for this position is expected to range between $81,200 and $150,800 per year. The final salary offered is determined based on factors such as relevant skills and experience, and upon joining Novartis it 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. Employees are also eligible for a generous time‑off package including vacation, personal days, holidays and other leaves.
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