QA Primary Loop at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's degree or equivalent (Science or Engineering related degree preferred)
Strong oral and written communication and interpersonal skills
Demonstrated decision making and problem-solving skills
Technical writing skills

Responsibilities

Lead, mentor, and coach Operations and support personnel on quality matters
Ensure regular presence in visual inspection operational areas to monitor GMP programs and quality systems
Collaborate cross-functionally as a core member of a manufacturing process team
Assess and triage deviations that occur within the local process team
Work with Lilly support groups and external partners to resolve or provide advice on product related issues
Participate in self-led inspections and provide support during internal / external regulatory inspections
Effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents)
Support project and process improvement initiatives for plant Process Teams

Skills

GMP compliance

deviation investigations

change control

batch disposition

validations

regulatory inspections

document review

quality systems

cross-functional collaboration

process improvement

visual inspection

manufacturing support

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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