QA Person in Plant - Drug Product External Manufacturing (Virginia) at Eli Lilly and Company

Richmond, Virginia, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Understand the science behind the process and equipment to ensure compliance-based decisions support effective and efficient processes
Know how upstream/downstream processing is affected by process steps
Know the Operational Control Strategy (OCS) and failure modes of the process
Know historical deviations/gaps, trends, and audit history of the process

Responsibilities

Lead a cross-functional team comprised of Lilly representatives
Provide help and guidance on deviation investigations, change control proposals, procedure/master formula revisions, and other daily duties
Perform final disposition of manufactured and/or packaged drug product batches
Serve as Drug Product External Manufacturing (DPEM) QA for initial escalation
Work with Lilly employees and Contract Manufacturer representatives as part of the Joint Process Team (JPT) to ensure timely responses to requests for information
Ensure batches meet specifications, are manufactured/packaged in accordance with validated processes, and comply with cGMP and regulatory requirements
Level, review, and approve event investigations and changes
Ensure implementation and effectiveness of corrective and preventative actions
Review that practice matches procedure
Ensure quality systems are compliant with applicable GMPs, Lilly quality standards, and local market requirements
Contribute to Quality culture efforts at DPEM and JPT
Spend time in all unit operations, including the lab
Provide primary oversight and guidance for minor investigations and change controls (initial notification and consult)
Support onsite resolution of product-related issues
Ensure compliance to data integrity (e.g., perform audit trail reviews)
Perform troubleshooting for in-process issues and escalate as needed
Review and provide approval for JPT procedure changes
Write protocols for non-routine testing or validation with appropriate guidance
Participate on Joint Process Teams (JPT)
Review, enter, or SPV analytical data and escalate as needed
Ensure batches are identified and appropriately sampled for annual stability requirements
Provide on-site support for GQAAC audits and Regulatory inspections
Review and approve complaint investigations
Consult on Master batch record updates and provide input based on floor observations and interactions
Track metrics
Assist in gathering data to complete Site Compliance Reports (SCR) and provide review as needed
Perform internal notification of quality issues where needed
Ensure materials and products manufactured at JPTs are released in compliance with marketing authorization requirements and applicable GMPs
Participate in JPT performance reviews (e.g., IOPs, supply management)
Track and monitor quality metrics for trends
Support batch release activities by completing batch record and media fill reviews (parenteral) and reporting issues
Determine final disposition of batches by reviewing all required documentation

Skills

cGMP

deviation investigations

change control

batch disposition

process validation

Operational Control Strategy

audit history

pharmaceutical manufacturing

cross-functional leadership

Joint Process Team

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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