Novartis Pharma Schweiz
The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.
Location: Indianapolis, IN; 2nd shift (14:30 - 23:00) Friday – Tuesday. Novartis is unable to offer relocation support for this role. Please only apply if the location is accessible for you.
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 to upscale any discrepancies immediately. Assist functional areas with achieving timely and compliant final product disposition of the product. Ensure specifications in place and are 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. CAPA management as well as 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 related relevant degree. In lieu of 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+ years of experience in a quality assurance role. Cross‑functional collaboration experience. 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. Compensation and Benefits
The salary for this position is expected to range between $81,200 and $143,000/year. The final salary offered is determined based on relevant skills and experience, and upon joining Novartis 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. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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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 to upscale any discrepancies immediately. Assist functional areas with achieving timely and compliant final product disposition of the product. Ensure specifications in place and are 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. CAPA management as well as 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 related relevant degree. In lieu of 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+ years of experience in a quality assurance role. Cross‑functional collaboration experience. 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. Compensation and Benefits
The salary for this position is expected to range between $81,200 and $143,000/year. The final salary offered is determined based on relevant skills and experience, and upon joining Novartis 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. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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