Quality Assurance Process Team Device Assembly and Packaging
About The Position
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. 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.
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 onsite (not eligible for remote work)
- Ability to work overtime as required
- 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.
Nice To Haves
- 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
Responsibilities
- Demonstrate leadership, teamwork, and quality knowledge on a day to day basis.
- Lead, mentor, and coach operations and support personnel on quality matters.
- Provide support on deviations, change controls, procedure updates, commissioning, and qualification activities.
- Have a regular presence in the operational areas to monitor and confirm execution according to quality standards.
- Participate on the local process team for one of the following manufacturing areas: Device Assembly or Packaging.
- Provide quality oversight for the verification and qualification of the manufacturing equipment, buildings, including review of test cases, test execution, discrepancy resolution, etc.
- Provide 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.
- 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.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
