Job Description Summary
The Senior QC Analytical Chemist is responsible for performing tasks associated with release testing and reviewing laboratory data. Communicating with and supporting internal & external partners of the Quality Control organization. Supports site as technical expert in related field.Location: Indianapolis, IN #LI-Onsite
Shift: Friday-Tuesday, 2nd (4 PM to 12:30 AM)
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.
Job Description
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.
- 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.
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
The salary for this position is expected to range between $85,400 and $158,600 per year.
The final salary offered is determined based on factors like, but not limited to, 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.
To learn more about the culture, rewards and benefits we offer our people click here .
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 +... and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$85,400.00 - $158,600.00Skills Desired
Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence