Quality Assurance Process Team Device Assembly and Packaging

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.

The Quality Assurance Process team member is responsible for demonstrating leadership, teamwork, and quality knowledge on a day to day basis. They are responsible to lead, mentor, and coach operations and support personnel on quality matters. They will provide support on deviations, change controls, procedure updates, commissioning, and qualification activities. This role will have a regular presence in the operational areas to monitor and confirm execution according to quality standards.

This role will participate on the local process team for one of following manufacturing areas:

• Device Assembly
• Packaging
• Project Focus for DAP

• Active presence in operational areas
• Provide quality oversight for the verification and qualification of the manufacturing equipment, buildings, including review of test cases, test execution, discrepancy resolution, etc.
• Provides guidance for leveling, resolving, reviewing and approving deviations and change controls
• Demonstrate a comprehensive understanding of the process and its associated equipment, facilities, computer systems and operations
• Lead and establish annual quality floor time plan
• Support resolution of batch documentation such as alarm response, exceptions, etc
• Support asset qualification monitoring reviews and reports
• Required to respond to operational issues outside of core business hours / days.
• Attend and provide update on quality at daily process team meeting
• Support the site organization in building technical capability, in Quality, the project team, and area process teams, including mentoring and training of new Quality staff
• Resolve or elevate any compliance issues to Quality Management
• Identify and implement continuous improvements
• Measure, maintain, and achieve quality metrics
• Serve as positive role models for their Process Team peers and for the organization in general

• Bachelors degree in a scientific field
• 4+ years’ experience in Quality pharmaceutical manufacturing required
• Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or P1-P4.

• ASQ Certified
• CSQA experience
• Previous experience with device assembly or packaging,
• Previous experience with Manufacturing Execution Systems.
• Previous use of KNEAT – or other electronic validation software
• Previous technical writing experience
• Use process knowledge and control strategy to make quality decisions
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills
• Ability to work independently as a Quality SME with minimal supervision
• Proficiency with computer systems including SAP, Trackwise, MES etc.
• Responsible for…