QA Operations Specialist

Job Description Summary

Job Description

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

• Bachelors' 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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $81,200 and $150,800/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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 e-mail 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.

Salary Range

Skills Desired