Quality Assurance Process Team Device and Packaging - Associate at Eli Lilly and Company

Concord, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

(Details are missing from the provided text.)

Responsibilities

Demonstrate leadership, teamwork, and quality knowledge on a day-to-day basis
Lead, mentor, and coach operations and support personnel on quality matters
Provide support on deviations, change controls, procedure updates, commissioning, and qualification activities
Maintain a regular presence in operational areas to monitor and confirm execution according to quality standards
Participate on the local process team for one of the following manufacturing areas: Device Assembly, Packaging
Active presence in operational areas
Provide quality oversight for the verification and qualification of the manufacturing equipment, buildings, including review of test cases, test execution, discrepancy resolution, etc
Provides guidance for leveling, resolving, reviewing, and approving deviations and change controls
Demonstrate a comprehensive understanding of the process and its associated equipment, facilities, computer systems, and operations
Lead and establish annual quality floor time plan
Support resolution of batch documentation such as alarm response, exceptions, etc
Support asset qualification monitoring reviews and reports
May be required to respond to operational issues outside of core business hours / days
Attend and provide updates on quality at daily process team meeting
Support the site organization in building technical capability, in Quality, the project team, and area process teams, including mentoring and training of new Quality staff
Resolve or escalate any compliance issues to Quality Management
Identify and implement continuous improvements
Measure, maintain, and achieve quality metrics
Serve as positive role models for the team

Skills

Quality Assurance

Deviation Management

Change Control

Equipment Qualification

Commissioning

Process Oversight

GMP Compliance

Batch Review

Test Case Review

Discrepancy Resolution

Manufacturing Processes

Device Assembly

Packaging

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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