Eli Lilly - Indianapolis, IN

posted 2 months ago

Full-time - Entry Level
Indianapolis, IN
5,001-10,000 employees
Chemical Manufacturing

About the position

The Associate/Senior Associate/Principal Associate - MQO role at Lilly focuses on supporting the development and implementation of GCP quality systems and activities that align with business goals. This position involves ensuring compliance, providing quality oversight, and facilitating audits and inspections, while collaborating with various business areas to enhance quality controls and processes.

Responsibilities

  • Implement and manage quality systems, including the development of procedures and resource documents.
  • Advise on training for implementation and documentation of quality systems.
  • Consult on root cause analysis and corrective/preventive actions (CAPA).
  • Monitor compliance to quality system documents and propose solutions for gaps.
  • Provide support for audits and inspections, ensuring readiness and completion of corrective action plans.
  • Function as the initial point of consultation for business areas on quality-related questions.
  • Coordinate quality improvement initiatives and review metrics to enhance processes.

Requirements

  • Bachelor's Degree in a science/technology/health care related field or equivalent work experience.
  • Demonstrated ability to apply GCP quality systems within a regulated work environment.

Nice-to-haves

  • Experience in a GCP quality control/quality assurance role.
  • Experience in GCPs related business areas such as clinical operations or clinical trial management.
  • Effective project and time management skills.
  • Strong interpersonal skills with demonstrated flexibility in varying environments.
  • Knowledge of GCP quality systems.

Benefits

  • Health insurance
  • Dental insurance
  • 401k
  • Paid holidays
  • Flexible scheduling
  • Professional development opportunities
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