QC Associate - Medical Device at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Medical DevicesIndustries

Requirements

Bachelor's degree in STEM discipline
Minimum of 1 year of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e.g., cGMP, 21 CFR 820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL)

Responsibilities

Provide Quality Control technical support for the IDM QC laboratory related to device testing for commercial and development product (e.g., design verification, process validation, stability, and batch release testing)
Support Event Management through roles of originator, executor, and investigator of quality observations/deviations and analytical investigations impacting the QC laboratory using root cause analysis
Support Change Management through roles of originator and executor, primarily completing impact analysis tasks and implementation steps
Serve as author, periodic reviewer, and/or subject matter expert (SME) for applicable IDM QC laboratory procedures, processes, and equipment, including training of laboratory personnel
Timely review and approval of GMP laboratory data and documentation: protocols, methods, technical reports, procedures, sampling plans, and rework/retest/resample instructions
Perform comprehensive technical review of lot release testing data generated by the IDM QC lab
Implement, maintain, and/or enhance appropriate quality systems within IDM QC laboratory
Build and maintain working relationships with DDCS, PRD, TS/MS, Lilly final Device Assembly/Packaging Sites, and Contract Manufacturers supporting batch release testing of Lilly product
Participate in new product design and pre-launch preparation projects to support device specification and test method development, laboratory equipment validation, and device testing
Participate in departmental process improvement activities (continuous improvement)
Participate in regulatory agency and internal inspections
Play a key role in the harmonization of global methods and support of local and global lab issues
Develop and maintain knowledge of applicable regulations, LQS, and GQS requirements in order to network and influence Lilly’s and the industry’s application

Skills

Quality Control

Medical Device Testing

Laboratory Operations

Root Cause Analysis

Event Management

Change Management

Process Validation

Stability Testing

Batch Release

Analytical Investigations

Design Verification

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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