Scientist Quality Assurance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Site Overview:

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Scientist-QA assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities.

Responsibilities:

The Scientist-QA for the Parenteral team provides oversight of the formulation or filling operations using isolator technology or visual inspection processes, assists and guidance to issues such as non-conformance investigations, change control proposals, procedures / master formula revisions, validations, sterility assurance, commissioning, and qualification activities. In addition, cross-train in the visual inspection area to support collaborative quality and production team environment.  

The Scientist-QA position is essential for maintaining GMP compliance and providing 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.

+ Ability to assess and triage deviations / observations that occur within Drug product formulation, filling and visual inspection processes.

+ Provides 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.

+ Responsible for adhering to safety rules and maintaining a safe work environment for yourself and others by supporting HSE corporate and site goals.

Basic Requirements:

+ Bachelor's Degree, preferred in a Science or Engineering related field

Additional Skills/Preferences :

+ 3 years of demonstrated experience in GMP facility.

+ Demonstrate knowledge and understanding of aseptic manufacturing process, isolator technology, visual inspection, and Quality Systems.

+ Ability to make technical decisions, provide guidance to the site and lead others.

+ Demonstrated strong oral and written communication skills, interpersonal skills and ability to work as a team.

+ Root cause analysis/troubleshooting skills.

+ Demonstrated attention to detail and ability to maintain quality systems.

+ Previous regulatory inspection readiness and inspection execution experience.

+ Proficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), Laboratory Information Management System (LIMS), Deviation Management Systems (Track Wise), Change Management.

+ CQA certification from the American Society for Quality (ASQ) or CSQA Experience.

+ Proficiency with computer systems including…