Novartis Pharma Schweiz
Quality Assurance(QA) Operations Specialist
Novartis Pharma Schweiz, Indianapolis, Indiana, us, 46262
Quality Assurance (QA) Operations Specialist
Novartis Pharma Schweiz – Indianapolis, IN (On‑site). Night Shift (Weekends). Please ensure you can access this location; no relocation support is offered.
Key Responsibilities
Provide shopfloor quality oversight of production, QC and supply chain departments to ensure full adherence to cGMP, including data integrity.
Ensure timely escalation of all applicable incidents to management.
Perform live review of manufacturing batch records in preparation for batch release and immediately address any discrepancies.
Assist functional areas with timely and compliant final product disposition.
Review, approve and support procedures and production/testing records, and assist in training site associates.
Ensure compliance of site personnel and enforcement of aseptic techniques; fully comply with sterile manufacturing regulations.
Support FDA/Regulatory interactions for Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
Support QA Operations as a valued business partner, fostering a culture of safety, quality, delivery to patients, cost control, compliance, and data integrity.
Perform other related duties as assigned.
Essential Requirements
Bachelor’s Degree, preferably in Life Sciences, Chemistry, or a related field. Alternatively, 5 years in a pharma quality assurance role.
2+ years in GxP Biopharmaceutical manufacturing operations.
1+ year in a quality assurance role.
Cross‑functional collaboration experience.
QA and QC experience in biotech/pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones (desired).
Practical experience with cGMP requirements.
Knowledge of FDA and EU regulations and experience with U.S. and international regulatory inspections.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Pharmaceutical Manufacturing
Salary & Benefits The salary is expected to range between $81,200 and $150,800 per year. The final amount will depend on relevant skills and experience and will be reviewed upon joining. Compensation includes a performance‑based cash incentive and, depending on the level, eligibility for annual equity awards. Eligible U.S. employees receive a comprehensive benefits package: health, life, disability, 401(k) with company match, plus a generous time‑off package (vacation, personal days, holidays, and other leaves).
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Key Responsibilities
Provide shopfloor quality oversight of production, QC and supply chain departments to ensure full adherence to cGMP, including data integrity.
Ensure timely escalation of all applicable incidents to management.
Perform live review of manufacturing batch records in preparation for batch release and immediately address any discrepancies.
Assist functional areas with timely and compliant final product disposition.
Review, approve and support procedures and production/testing records, and assist in training site associates.
Ensure compliance of site personnel and enforcement of aseptic techniques; fully comply with sterile manufacturing regulations.
Support FDA/Regulatory interactions for Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
Support QA Operations as a valued business partner, fostering a culture of safety, quality, delivery to patients, cost control, compliance, and data integrity.
Perform other related duties as assigned.
Essential Requirements
Bachelor’s Degree, preferably in Life Sciences, Chemistry, or a related field. Alternatively, 5 years in a pharma quality assurance role.
2+ years in GxP Biopharmaceutical manufacturing operations.
1+ year in a quality assurance role.
Cross‑functional collaboration experience.
QA and QC experience in biotech/pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones (desired).
Practical experience with cGMP requirements.
Knowledge of FDA and EU regulations and experience with U.S. and international regulatory inspections.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Pharmaceutical Manufacturing
Salary & Benefits The salary is expected to range between $81,200 and $150,800 per year. The final amount will depend on relevant skills and experience and will be reviewed upon joining. Compensation includes a performance‑based cash incentive and, depending on the level, eligibility for annual equity awards. Eligible U.S. employees receive a comprehensive benefits package: health, life, disability, 401(k) with company match, plus a generous time‑off package (vacation, personal days, holidays, and other leaves).
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