摘要
Location: Indianapolis, IN #LI-Onsite
Shift: Thursday- Sunday 1st (AM)
About the Role
Key Responsibilities:
- Provide support to peers within the Quality Assurance, Quality Control and AS&T teams.
- On-time and GMP-compliant release of patient batches
- Support Quality Control and AS&T as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
- QC primary point of contact towards raw materials incoming testing, inventory management, and vendor interface
- Author, review and support procedures, investigations, corrective and preventive actions, change controls, complaints, and training as it relates to quality control testing.
- Ensure that QC testing is properly conducted and documented for all performed activities, with emphasis on Data Integrity. Evaluate and approve QC records as required.
- Provide oversight and monitoring of quality control KPIs and programs.
- Perform QC related validations, transfers, improvements, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Control systems.
- Prepare and participate in health authorities’ inspections and internal audits of QC. Ensure quality control area is inspection ready.
Please note:
• This position may involve shift work which will be defined through site commercialization needs.
• This position may involve on-call shifts, if required, when scheduled.
Essential Requirements:
- BSc in Chemistry or relevant scientific discipline
- 5+ years of experience in a GMP quality control environment
- General HSE Knowledge
- Knowledge of GMP Manufacturing Process Execution
- Quality Control (QC) Testing
- Quality Control Sampling
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $85,400 and $158,600/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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
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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 & 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 [email protected] 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.
