Associate - Quality Assurance at Eli Lilly and Company

Carolina, Puerto Rico, Puerto Rico

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Adhere to standard operating procedures and current Good Manufacturing Practices (GMP)
Understand the Global Quality Standards (GQS) and Common Quality Practices (CQP) and how they apply to Process Team operations
Understand the science behind the process and equipment to facilitate science-based decision making
Know how upstream/downstream processing is affected by process steps
Know the Operational Control Strategy and potential failure modes of the process
Know the historical deviations/gaps, trends, and audit history of the process

Responsibilities

Support production: review/approve procedures and master formulas
Provide Quality Assurance oversight to GMP operations
Conduct analytical data review
Provide coaching and feedback to operational staff
Participate in and/or lead self-inspection activities
Perform batch disposition, audit trail reviews, review by exceptions including Delta V interventions
Maintain relationship with regulatory resources
Contribute to the achievement of key departmental objectives including safety performance, reducing deviations, and training compliance
Evaluate batch production records
Ensure documentation is created using good technical writing
Ensure that deviations are investigated and resolved in a timely manner
Serve as instructor of GMP and Quality related Standard Operating Procedures (SOP)
Educate the Process Team and operators on Global Quality Standards (GQS) and Common Quality Practices (CQP)
Perform classification, review and approval of observations and changes
Use statistical data to understand the sources of variability and to continuously improve the process
Review that practice matches procedure on the production floor
Ensure the Quality Systems complies with the Quality Standards
Serve as a liaison between the Process Team and other Quality areas (Laboratories, Compliance, Incoming, etc.)
Review and approve deviations assuring robustness of Root Cause Analysis and effectiveness of Corrective Actions/Preventive Actions (CAPA)
Assist in regulatory inspections
Escalate quality issues from manufacturing to the site-based process team
Notify and escalate to quality management significant quality or compliance related issues
Provide visibility on metrics related to change controls and deviations and any other quality key performance indicator as needed
Review, identify, and drive alignment of Quality Assurance systems across the supported operation
Review and identify opportunities for continuous improvement and Simplification and assist in prioritization of opportunities with respect to overall business objectives
Collaborate with key support groups around the development of process knowledge and a common process improvement agenda
Serve as liaison between Frontline Associate Quality and key Lilly affiliates quality personnel, Global Quality Unit during the consultation of Quality and Regulatory policies (e.g., Global Quality Standard (GQS), Lilly Quality Practices)

Skills

Key technologies and capabilities for this role

GMPDeviation InvestigationsChange ControlBatch DispositionValidationSOPQuality AssuranceAnalytical Data ReviewSelf-InspectionAudit Trail ReviewsGood Technical WritingGlobal Quality Standards

Questions & Answers

Common questions about this position

What is the employment type for this Associate - Quality Assurance position?

The position is full time.

Is this a remote position, or is there a required location?

This information is not specified in the job description.

What key skills are required for the Associate - Quality Assurance role?

Key skills include knowledge of GMP, Global Quality Standards (GQS), and Common Quality Practices (CQP), conducting deviation investigations and root cause analysis, reviewing batch records and analytical data, and providing coaching on SOPs.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and emphasizes giving best effort to work while contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for this Quality Assurance Associate role?

Strong candidates understand the science behind processes and equipment, know GMP compliance, Global Quality Standards, and process failure modes, and have skills in deviation investigations, root cause analysis, batch review, and coaching operational staff.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free