QA Dry External Manufacturing (Drug product & Packaging) Associate at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences
3+ years previous GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering
Must complete required training for Dry-EM Quality Assurance

Responsibilities

Serve as a liaison between CMs and Lilly
Provide quality oversight of CMs including being the initial point of contact for all quality-related issues
Escalate quality issues at CMs to Lilly QA management
Assist in the establishment and revisions of Quality Agreements with affiliates and customers
Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs)
Provide quality oversight of Lilly/Dry-EM Quality Plans
Coordinate and perform QA responsibilities of Bulk/finished product shipments
Participate in regulatory inspection preparations with CMs and provide on-site support during inspections
Participate on the Technical Review Board
Evaluate and disposition batches of bulk and finished product, if required
Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release
Provide quality support of the manufacturing process for bulk (capsules and tablets) and packaged products with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures
Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable
Ensure all processes are in an appropriate state of control
Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product
Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations
Participate in APR activities
Participate in projects to improve productivity
Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams

Skills

cGMP

Quality Assurance

Regulatory Compliance

Batch Disposition

Quality Agreements

Deviation Management

Change Control

Environmental Monitoring

Inspection Preparation

Technical Review

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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