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Quality Assurance Compliance Analyst

2 months ago


Indianapolis, Indiana, United States Novartis Full time
Job Overview

Position Summary:
This role is a temporary contractor position at Novartis, a company that significantly impacts the health of millions worldwide.

About the Role:
The Quality Assurance Compliance Analyst is responsible for establishing and maintaining effective Quality Systems in alignment with Novartis and regulatory standards. This position plays a crucial role in the execution of these systems, contributing to the development of procedures and ensuring timely implementation. Key responsibilities include:

  • Overseeing the creation and management of comprehensive quality systems at the site level.
  • Leading the Quality Management Review (QMR) program, including the monitoring and reporting of essential performance metrics.
  • Collaborating with management to implement and maintain the Inspection Readiness program, ensuring compliance with corporate and global health authority inspections.
  • Facilitating training sessions on all aspects of QA Compliance.
  • Assisting in the implementation and upkeep of critical programs such as the Annual Product Quality Review (APQR) and Compliance Alerts.
  • Contributing to site inspection preparations and managing responses to findings.
  • Identifying and escalating quality risks as per established procedures.
  • Representing QA Compliance in project teams and discussions.
  • Promoting continuous improvement within QA Compliance programs and exploring new technologies to enhance compliance and efficiency.
  • Ensuring adherence to Good Manufacturing Practices (GMP).

Location:
Indianapolis, IN (Onsite)

Compensation:
$56-$72/hour
Contract Duration: 6 months
Benefits: Health, dental, vision, 401k

Why Choose Novartis?
In 2021, Novartis touched the lives of 766 million individuals through its medicines. The company is committed to improving and extending lives through innovative solutions at the intersection of medical science and digital technology. A diverse and inclusive environment fosters creativity and collaboration, enabling the tackling of the world's most pressing medical challenges.

Commitment to Diversity & Inclusion:
Novartis is dedicated to creating an outstanding and inclusive workplace with diverse teams that reflect the communities we serve. We believe that diverse perspectives lead to better outcomes, and we celebrate inclusion in all its forms.

Accommodation:
If you require reasonable accommodation during the application process or any related activities, please reach out for assistance.