Principal Associate-Quality Assurance-CSQ at Eli Lilly and Company

Carolina, Puerto Rico, Puerto Rico

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

BS in Engineering or Computer System Engineering (minimum)
Minimum 3 to 5 years of experience in computer system validation and data integrity role
Experience working in a manufacturing, pharmaceutical QA, QC, Technical Services or Regulatory Affairs and/or GMP facility
Fully bilingual (Spanish / English)
Self-driven and teamwork oriented
Strong written and verbal communication skills
Problem solving skills, critical thinking
Able to work irregular hours, weekends and/or holidays as needed

Responsibilities

Perform Computerized System Validation (CSV) Audit Trail Review for Systems applications and data audit trail review
Provide support in the review and approval of validation protocols and change control documents, as allowed by system audit trail schedule
Participate in the periodic monitoring review of computerized systems
Provide consultation and interpretation on CSQ expectations and regulatory aspects on computer systems validation

Skills

Key technologies and capabilities for this role

Computerized System ValidationCSVAudit Trail ReviewData IntegrityValidation ProtocolsChange ControlGMPPharmaceutical QAQCRegulatory Affairs

Questions & Answers

Common questions about this position

What education and experience are required for this Principal Associate-Quality Assurance role?

A BS in Engineering or Computer System Engineering is required, along with a minimum of 3 to 5 years of experience in computer system validation and data integrity roles.

What additional skills are needed for this position?

Candidates must be fully bilingual in Spanish and English, self-driven and teamwork oriented, with strong written and verbal communication skills, problem-solving abilities, critical thinking, and availability to work irregular hours, weekends, or holidays as needed.

What are the main responsibilities in this QA role at Eli Lilly?

The role involves performing Computerized System Validation (CSV) Audit Trail Review for systems applications and data, supporting review and approval of validation protocols and change control documents, participating in periodic monitoring reviews of computerized systems, and providing consultation on CSQ expectations and regulatory aspects.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position, or what is the location requirement?

This information is not specified in the job description.

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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