Quality Assurance Representative
3 weeks ago
We’re looking for people who are determined to make life better for people around the world.
Organization 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 Quality Assurance Representative assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities.
Responsibilities:
The Quality Assurance Representative for the Parenteral team provides oversight of the filling operations using isolator technology, 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 Quality Assurance Representative 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 development fill 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 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:
Additional Skills/Preferences:
Additional Information:
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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