Eli Lilly and Company

Lead Specialist-QA-Shift-EM

Suzhou, Jiangsu, China

$60,000 – $80,000Compensation
Mid-level (3 to 4 years), Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical Manufacturing, Quality Assurance, Environmental MonitoringIndustries

Requirements

Candidates should possess a strong understanding of environmental monitoring and clean utility systems, with demonstrated experience in microbiological and particle sampling within classified areas. They should also have experience with data integrity requirements and adherence to HSE procedures, along with the ability to correctly wear PPE. Furthermore, the ideal candidate will have experience with quality system compliance and technical instruction, including the ability to write and revise operating instructions and qualification documents.

Responsibilities

The Lead Specialist-QA-Shift-EM will be responsible for correctly applying HSE procedures and wearing appropriate PPE during daily operations, ensuring data integrity, following procedures for microbiological and particle sampling, executing environmental monitoring sampling, and performing quality monitoring of clean utility systems. They will also arrange daily work, confirm sampling plans, ensure sample life cycles are complete, provide technical guidance for sampling operations, utilize electronic systems or paper documents to maintain monitoring data, and ensure necessary materials and equipment meet operational needs. Additionally, the role involves providing technical support for environmental monitoring and clean utilities, writing and managing revision of operating instructions and qualification documents, offering training, participating in Environmental Monitoring Performance Qualification (EMPQ), assisting in root cause investigations, and participating in team meetings while fostering open communication and collaboration.

Skills

Data Integrity
HSE Procedures
Microbiological Sampling
Particle Sampling
Environmental Monitoring
Quality System Compliance
Operating Instructions
Qualification Documents
PPE
Root Cause Investigation
Technical 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.

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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