Job Description Summary
Location: Indianapolis, IN #LI-OnsiteAbout this role:
The QC 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 is also required.
Job Description
Major accountabilities:
- Provide support to peers within the Quality Assurance, Quality Control and AS&T teams.
- On-time and GMP-compliant release of dosage forms
- 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
- 3+ years of experience in a GMP quality control environment
- Strong HPLC experience a must
- General HSE Knowledge
- Knowledge of GMP Manufacturing Process Execution
- Quality Control (QC) Testing
- Quality Control Sampling
- Dealing With Ambiguity.
- GMP Procedures
- Quality Control (Qc) Testing.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
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
$97,600.00 - $146,400.00
Skills Desired
Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence