QA Process Lead - Device Assembly & 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

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