Scientist Quality Assurance

Site Overview

Lilly is designing and building a new state‑of‑the‑art Parenteral, Device, and Packaging Assembly Facility in Raleigh‑Durham, North Carolina. The Scientist‑QA will help establish the facility’s quality system from the ground up.

• Provide oversight of formulation or filling operations using isolator technology or visual inspection processes.
• Assist with non‑conformance investigations, change control proposals, procedure and master formula revisions, validations, sterility assurance, commissioning, and qualification activities.
• Cross‑train in the visual inspection area to support a collaborative quality and production environment.
• Maintain GMP compliance and support preparations for pre‑approval/general inspections by regulatory agencies.
• Support the site readiness plan focusing on operations process and startup of new systems.
• Review and approve GMP documents, including non‑conformances, procedures, protocols, specifications, and change controls.
• Participate in local process teams and project support activities, leading and mentoring operations and support personnel on quality matters.
• Triage deviations and observations within drug product formulation, filling, and visual inspection processes, providing guidance to ensure robust Quality Systems.
• Support project and process improvement initiatives for plant process teams as the representative of the Quality function.
• Approve commissioning, qualification, and validation documents for equipment to ensure compliance with quality standards.
• Liaise with Lilly support groups and external partners to resolve product‑related issues.
• Participate in self‑led inspections and support internal and external regulatory inspections.
• Adhere to safety rules and maintain a safe work environment.

Bachelor’s degree, preferably in a science or engineering related field.

• At least 3 years of demonstrated experience in a GMP facility.
• Knowledge and understanding of aseptic manufacturing processes, isolator technology, visual inspection, and Quality Systems.
• Ability to make technical decisions and lead others.
• Strong oral and written communication and interpersonal skills for teamwork.
• Root cause analysis and troubleshooting skills.
• Attention to detail and ability to maintain quality systems.
• Experience with regulatory inspection readiness and execution.
• Proficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), LIMS, Deviation Management Systems (Track Wise), and Change Management.
• CQA certification from ASQ or CSQA experience.
• Proficiency with Microsoft Office products.
• Ability to work independently or as part of a team to resolve issues.

Support for a 24/7 manufacturing operation.

Flexible working environment with ability to work remotely 2–4 days a month.

Salary range: $65,250 – $148,500 per year. Full‑time employees are also eligible for a company bonus based on performance.

Benefits include 401(k) participation, pension, vacation, medical, dental, vision, prescription drug coverage, flexible benefits such as healthcare and dependent day‑care flexible spending accounts, life and death insurance, leave of absence, employee assistance program, fitness benefits, and employee clubs and activities.

Lilly is proud to be an EEO employer and does not discriminate on any protected basis. Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. Lilly will provide accommodations during the application and interview process.