神戸本社 at Eli Lilly and Company

Kobe, Hyogo, Japan

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Full-time employment
Ability to serve as a subject matter expert (SME) for applicable systems, procedures, and work instructions
Ability to act as an instructor
Compliance with Lilly Global/Local Quality Systems and Global/Local regulations

Responsibilities

Open and receive returned complaint samples and prepare them for analysis
Perform visual and/or functional analysis of returned complaint samples
Assess sample analysis results, including complaint level, categories, investigation site, and additional investigation needs
Assign and forward complaint samples to designated manufacturing or packaging sites for further investigation as needed
Handle import, export, and/or destruction of complaint samples following required procedures
Maintain complaint products and lab supplies
Conduct cleaning and maintenance of laboratory and equipment
Assess product complaint information, including designating complaint levels and categories
Determine need for additional investigation and forward records to appropriate manufacturing or packaging quality units
Determine the need for investigation of product complaint samples
Build and maintain relationships with manufacturing/packaging sites to ensure timely complaint investigations
Obtain additional details on complaints from affiliates or related contacts as necessary
Evaluate completed investigation results and identify possible root causes
Obtain supplementary information from related parties to aid root cause determination when needed
Communicate with affiliates or contacts, including educational information during follow-ups
Document assessment and analysis results in the complaint database and associated records
Review records for completeness and compliance with Global Quality Standards
Work effectively as a team to deliver results within defined timelines and manage operations
Participate in supporting/supplemental activities, improvement activities, and oversight/monitoring activities
Maintain related IT systems

Skills

Key technologies and capabilities for this role

Sample AnalysisVisual InspectionFunctional AnalysisComplaint AssessmentLaboratory MaintenanceEquipment MaintenanceImport ProceduresExport ProceduresSample DestructionQuality Assurance

Questions & Answers

Common questions about this position

What is the location for this Quality Assurance position?

The role is based at the Kobe headquarters (神戸本社).

What is the salary or compensation for this role?

This information is not specified in the job description.

What key responsibilities are involved in this position?

Key responsibilities include sample analysis of complaint products (visual and functional inspections), assessment of complaint levels and categories, collaboration with manufacturing sites for investigations, and maintenance of lab equipment and supplies.

What is the company culture like at Eli Lilly?

Eli Lilly emphasizes uniting caring with discovery to make life better for people, putting people first, and giving best effort to work while seeking determined individuals to improve lives globally.

What makes a strong candidate for this Associate role in Quality Assurance?

Strong candidates should have skills in sample handling, visual/functional analysis, complaint assessment, cross-functional collaboration with manufacturing sites, root cause analysis, and maintaining lab operations.

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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