Quality Assurance; QA Operations Specialist

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.

• 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.

• 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.

Mid‑Senior level

Full‑time

Quality Assurance

Pharmaceutical Manufacturing

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).