Quality Assurance Process Team Device and Packaging - Associate

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:

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.

Responsibilities:

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

Responsibilities include:

• 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
• May be 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 escalate 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

Basic Requirements:

• Bachelors or equivalent 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
• 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 maintaining a safe work environment,
• Ability to work 8 hour shifts o