Quality Assurance Representative - Parenteral

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. 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:

• Bachelor’s or equivalent (Science or Engineering related degree preferred).
• Minimum of 5 years of demonstrated experience in GMP facility.

Additional Skills/Preferences:

• 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 (TrackWise), Change Management.
• CQA certification from the American Society for Quality (ASQ) or CSQA Experience
• Proficiency with computer systems including Microsoft office products.
• Proven ability to work independently or as part of a team to resolve issues.

Additional Information:

• Support for 24/7 manufacturing operation.
• Flexible working environment with the ability to work remotely 2 – 4 days a month.

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