Scientist - Quality Assurance at Eli Lilly and Company

Durham, North Carolina, 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, Healthcare, BiotechnologyIndustries

Requirements

Bachelor’s in a Science or Engineering related field
Minimum of 5 years of demonstrated experience in GMP facility
Demonstrate knowledge and understanding of aseptic manufacturing process, isolator technology

Responsibilities

Provide oversight of the formulation or filling operations using isolator technology or visual inspection processes
Assist and provide guidance on issues such as non-conformance investigations, change control proposals, procedures/master formula revisions, validations, sterility assurance, commissioning, and qualification activities
Cross-train in the visual inspection area to support collaborative quality and production team environment
Maintain GMP compliance and provide support during preparation for pre-approval/general inspections by various regulatory agencies
Support the site in the development and execution of the site readiness plan with focus on supporting operations process and startup of new systems
Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls)
Active on local process teams or indirect participation through project support activities
Lead, mentor, and coach operations and support personnel on quality matters
Assess and triage deviations/observations that occur within Drug product formulation, filling and visual inspection processes
Provide guidance in operational areas to ensure robust Quality Systems and GMP compliance
Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function
As applicable, approve commissioning qualification/validation documents for equipment to ensure compliance with quality standards
Liaison with Lilly support groups and external partners to resolve or provide advice on product related issues
Participate in self-led inspections and provide support during internal/external regulatory inspections
Adhere to safety rules and maintain a safe work environment for yourself and others by supporting HSE corporate and site goals

Skills

Key technologies and capabilities for this role

Quality AssuranceNon-conformance InvestigationsChange ControlFormulationFilling OperationsIsolator TechnologyVisual InspectionGMPPharmaceutical Manufacturing

Questions & Answers

Common questions about this position

What is the location for this Quality Assurance Scientist position?

The role is based at Lilly's state-of-the-art facility production site in Research Triangle Park (Raleigh-Durham, North Carolina).

What does Eli Lilly's company culture emphasize?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, gives best effort to work, and seeks determined individuals while contributing to communities through philanthropy and volunteerism.

What are the main responsibilities of the Scientist-QA role?

The role involves providing quality oversight for formulation or filling operations, reviewing GMP documents like non-conformances and change controls, leading process teams, mentoring personnel, and supporting regulatory inspections and site readiness.

What experience is needed for this Quality Assurance Scientist position?

Lilly is seeking experienced Quality Assurance Scientists with expertise in areas like non-conformance investigations, change control, validations, sterility assurance, GMP compliance, and operations in formulation or filling using isolator technology.

What makes a strong candidate for this Scientist-QA role at Lilly?

Strong candidates have experience in quality assurance for manufacturing, particularly in parenteral formulation or filling, with skills in GMP documentation, deviation triage, mentoring teams, and supporting regulatory inspections in a collaborative environment.

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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