Eli Lilly and Company

Associate/Sr. Associate - QA API

Indianapolis, Indiana, United States

Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Quality AssuranceIndustries

Requirements

Candidates must hold a Bachelor's degree in Engineering or a science-related field, or possess equivalent experience. A minimum of 2 years of Quality Assurance experience is required, along with preferences for experience with computer system validation, strong written and verbal communication skills, attention to detail, proficiency with computer system applications, knowledge of cGMPs and quality systems, understanding of statistical tools and analysis, and excellent interpersonal skills.

Responsibilities

The Associate – QA – IAPI will provide direct quality oversight of production, warehouse/material management, engineering, automation, and laboratory operations, reviewing and approving documents such as procedures and change control proposals. They will also provide quality guidance, participate in aberrant data investigations, conduct analytical data review, disposition API Intermediates and raw materials, provide coaching and mentoring, investigate customer complaints, participate in recalls, contribute to reviews, conduct gap assessments, participate in self-inspection activities, support regulatory inspections and audits, maintain and improve quality systems, and assist others in interpreting regulatory requirements.

Skills

cGMPs
quality systems
statistical tools
data analysis
computer system validation
change control proposals
regulatory inspections
audits
gap assessments
customer complaints
recalls
interpreting regulatory requirements

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.

Key Metrics

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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