Quality Assurance Process Team Device Assembly and Packaging

Eli Lilly and Company; Concord (NC); On-site; USD 65,250 - 169,400; Full time

Job summary

Lilly is seeking a Quality Assurance Process Team member to lead and mentor operations on quality matters and support deviations, change controls, and commissioning activities. You will maintain a regular presence in manufacturing areas to ensure execution meets quality standards with a focus on continuous improvement and regulatory compliance.

Responsibilities include overseeing verification and validation for equipment, leading the annual quality floor time plan, and guiding deviations and

Qualifications

• Bachelor's or equivalent degree in a scientific field.
• 4+ years’ experience in quality pharmaceutical manufacturing required.
• Experience with C&Q / Verification and Validation oversight including automation and computer systems validation.
• Knowledge of US/EU/Japan regulations in pharmaceutical manufacturing.
• Strong communication skills across cross-functional teams.
• Ability to work independently as a Quality SME with minimal supervision.
• Proficiency with SAP, Trackwise, MES.
• Must be legally eligible to work in the United States; no visa sponsorship anticipated.
• On-site 8-hour shifts; no remote work.
• Overtime as required.

Responsibilities

• Active presence in operational areas.
• Provide quality oversight for 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
• Required to 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 elevate 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 for the organization in general

Skills

Quality leadership

Quality decision making

Communication skills

Regulatory knowledge

Problem solving

Education

Bachelor's degree in a scientific field

Tools

SAP

Trackwise

MES

KNEAT

Electronic validation software

Job description

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—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.

Responsibilities

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

• 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.
• 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
• Required to 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 elevate 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 for the organization in general

Basic Requirements

• Bachelor's 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.

Additional Skills/Preferences

• 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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. This is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is a proud EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 – $169,400. Full‑time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefits program including 401(k) participation, pension, vacation benefits, medical, dental, vision and prescription drug benefits, flexible benefits such as healthcare and/or dependent day‑care flexible spending accounts, life insurance and death benefits, certain time‑off and leave of absence benefits, and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.