Job Description Summary

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.

Location: Indianapolis, IN #LI-Onsite
Shift- 1st Thursday-Sunday

Job Description

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.

Please note:

This position involves shift work which will be defined through site start up and commercialization readiness.
This position involves on-call shifts, if required, when scheduled.

Essential Requirements:

BSc in Chemistry or relevant scientific discipline
3+ years of experience with HPLC in pharmaceutical industry
Knowledge of radioisotopes preferred
General HSE Knowledge
GXP experience required ; knowledge of GMP Manufacturing Process Execution preferred
Quality Control (QC) Testing and Quality Control Sampling

The pay range for this position at commencement of employment is expected to be between $97,600 and $146,d400 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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 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