Sr. Associate, Quality Assurance - CAPA Lead at Eli Lilly and Company

Pleasant Prairie, Wisconsin, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, ManufacturingIndustries

Requirements

Bachelor's degree in a science, engineering, or related field

Responsibilities

Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals
Leads, mentors, and coaches operations and support personnel on the deviation management system and CAPA program
Facilitates the Site Deviation and CAPA review board, providing board leadership to drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence
Creates and maintains the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems
Compiles and presents CAPA program health metrics to the Site Quality Lead Team with proposed actions
Monitors deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner
Acts as a site instructor for Deviation Management courses
Coaches lead investigators on technical writing
Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures
Supports and initiates deviations, trends, or other technical investigations, as applicable
Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding
Works with the network deviation program mentor to benchmark and replicate best practices

Skills

Quality Assurance

CAPA

Deviation Management

Quality Management System

QMS

Regulatory Compliance

Root Cause Analysis

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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