Associate - QA Batch Disposition at Eli Lilly and Company

Concord, North Carolina, United States

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, ManufacturingIndustries

Requirements

Bachelor’s degree in STEM
Experience working in the pharmaceutical or medical device industry in QA roles
Previous batch disposition experience
Ability to make technical decisions and provide guidance to the site
Proficiency with applicable computer systems
Demonstrated strong oral and written communication skills
Demonstrated interpersonal skills and the ability to work as a team
Root cause analysis/troubleshooting skills
Demonstrated attention to detail and ability to maintain quality systems
Previous regulatory inspection readiness and inspection execution experience
Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites
Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals
Legally authorized to be employed in the United States (no sponsorship anticipated)

Responsibilities

Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems
Perform final batch disposition of semi-finished and/or finished drug product and combination product batches to ensure high quality medicine (GMP Compliance) is released to market in a timely manner
Effectively own/review/approve GMP documents to ensure quality attributes are met (i.e.: Deviations, procedures, protocols, specifications, and change controls)
Additional job duties as required

Skills

Key technologies and capabilities for this role

GMP complianceQuality AssuranceBatch DispositionElectronic Batch RecordsData IntegrityValidationQualificationManufacturing OversightRegulatory ComplianceParenteral Manufacturing

Questions & Answers

Common questions about this position

What are the basic requirements for the Associate - QA Batch Disposition role?

Candidates need a Bachelor’s degree in STEM, experience in the pharmaceutical or medical device industry in QA roles, previous batch disposition experience, ability to make technical decisions, proficiency with computer systems, strong communication skills, interpersonal skills for teamwork, and root cause analysis/troubleshooting abilities.

Where is the QA Batch Disposition position located?

The role is at Lilly's new state-of-the-art manufacturing site in Concord, North Carolina.

What is the salary or compensation for this position?

This information is not specified in the job description.

What does Lilly's company culture emphasize?

Lilly unites caring with discovery to make life better for people, puts people first, and seeks determined individuals; the Concord site focuses on innovative high-tech manufacturing with environmental responsibility.

What makes a strong candidate for this QA Batch Disposition role?

A strong candidate has prior batch disposition experience in pharma or medical devices, a STEM degree, and skills in technical decision-making, GMP document review, root cause analysis, and teamwork.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free