Eli Lilly and Company

QA Representative - Warehouse 3rd Shift

Durham, North Carolina, United States

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

Requirements

Candidates should possess a Bachelor’s degree in a related scientific or technical field, and demonstrate at least 3 years of experience in a quality assurance role within a pharmaceutical or regulated manufacturing environment. Strong knowledge of GMP regulations, FDA guidelines, and relevant quality systems is essential, along with experience in non-conformance investigations, change control, and CAPA management.

Responsibilities

The Quality Assurance Representative will provide daily oversight and guidance on issues such as non-conformance investigations, change control proposals, and procedure revisions, focusing on automated warehouse operations. They will actively monitor GMP programs and quality systems within the warehouse, device assembly, and packaging areas, lead and mentor operations personnel on quality matters, assess and triage deviations, and support internal and external regulatory inspections. Additionally, the role involves reviewing and redlining documents to ensure quality attributes are met, participating in Six Sigma projects, and supporting project and process improvement initiatives related to warehousing processes.

Skills

GMP
FDA guidelines
Quality systems
Non-conformance investigations
Change control
CAPA management
Deviations
Regulatory inspections
Document review
Six Sigma

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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