Supervisor – QA Incoming at Eli Lilly and Company

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

High school diploma or GED
Preferred: Previous materials or warehouse experience
Preferred: Previous experience leading and managing a team
Preferred: Demonstrated understanding of cGMP regulations related to QA Inspection applications
Preferred: Strong attention to detail
Preferred: Proficiency (inferred from incomplete text)

Responsibilities

Practice safety behaviors with proper PPE and lifting techniques; support all HSE Corporate and Site Goals
Manage the QA – Incoming team, consisting of 8-12 Quality Specialists
Train and manage the QA – Incoming team in performing incoming inspections (raw materials, components, printed packaging materials, etc.) according to priority
Ensure team documents inspections in accordance with procedures and specifications
Ensure materials not meeting specifications are quarantined, per local procedures
Oversee sampling, inspecting, and documenting results utilizing electronic systems (Darwin, SmartLab, etc.)
Ensure proper sampling plan is followed when sampling a portion of the batch
Work with the QC Lab to deliver samples and receive results
Perform ID testing of materials utilizing Raman or NIR Spectroscopy
Maintain retains and samples per local procedures
Communicate with QA Disposition team to ensure materials are released in a timely manner to avoid delaying production
Evaluate damaged materials found on inbound shipments or within the warehouse and determine acceptability
Ensure storage conditions are tracked, accurate, and adjusted (as needed), including evaluating temperature excursions on shipments
Assist in resolving issues on inbound shipments (e.g., incorrect quantity or product, contamination, etc.)
Perform appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.)
Provide additional Quality support to warehouse, as necessary
Assist with performing department activities to ensure materials are available for production
Ensure team is trained and training remains in compliance
Communicate with Associate Director and Quality Representatives on quality issues
Lead, mentor, and coach QA – Incoming team, Operations, and support personnel on quality matters, while supporting and driving the site Quality culture
Ensure regular presence in operational areas to monitor GMP programs and quality systems
Work with materials management group to initiate complaints/remarks to supplier for materials not meeting Lilly expectations
Participate in investigations regarding materials or service complaints
Network with the business and ensure all materials are dispositioned in a timely manner to support production schedule
Author/revise SOPs, materials specifications, as needed
Interact with other quality functions including QA Warehouse
Support material related Supplier Change Notifications (SCN)
Participate in/support regulatory inspections, as needed

Skills

Key technologies and capabilities for this role

Incoming InspectionSamplingRaman SpectroscopyNIR SpectroscopyDarwinSmartLabMaterial QuarantinePPETeam ManagementQuality AssuranceElectronic DocumentationQC Lab Coordination

Questions & Answers

Common questions about this position

What is the salary for the QA Supervisor – Incoming role?

This information is not specified in the job description.

Where is this position located?

The position is at Lilly's new state-of-the-art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham, North Carolina.

What are the key responsibilities of the QA Incoming Supervisor?

The role involves managing a team of 8-12 Quality Specialists, overseeing incoming materials inspection processes including sampling, testing, documentation, and quarantine, and ensuring compliance with procedures using systems like Darwin and SmartLab.

What is the team size for the QA Incoming group?

The QA – Incoming team consists of 8-12 Quality Specialists.

What makes a strong candidate for this supervisor role?

Strong candidates should have leadership experience to manage and train a team of 8-12, knowledge of incoming inspection processes, proficiency with electronic systems like Darwin and SmartLab, and skills in quality assurance including sampling, spectroscopy, and SAP transactions.

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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