QC Chemist

Summary

Location: Indianapolis, IN #LI-Onsite

Shift:Thursday - Sunday first shift 4x10 hrs. This position may involve mandatory overtime as needed.

About 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.

About the Role

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.

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?