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.

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.
• Regular presence in operational areas to monitor and confirm execution according to quality standards.
• Participate on the local process team for Device Assembly Packaging (DAP).
• Provide quality oversight for the verification and qualification of 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 an 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 updates on quality at daily process team meetings.
• 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 a positive role model for Process Team peers and the organization.

Requirements

• Bachelor’s degree in a scientific field.
• 4+ years’ experience in Quality pharmaceutical manufacturing.
• Previous experience with Commissioning & Qualification (C&Q) / Verification and Validation oversight including automation and computer systems validation.
• Legally authorized to be employed in the United States; Lilly does not anticipate providing sponsorship for employment visa status.

Skills

• ASQ Certified or CSQA experience.
• Previous experience with device assembly or packaging.
• Previous experience with Manufacturing Execution Systems (MES).
• 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 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.

Benefits

• Eligibility to participate in a company-sponsored 401(k) and pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and 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).
• Company bonus (depending, in part, on company and individual performance).

Pay

The anticipated wage for this position is $65,250 - $169,400.

Schedule

• Full-time, onsite.
• 8-hour shifts.
• Overtime as required.
• Required to respond to operational issues outside of core business hours/days.