QA Process Lead, Device Assembly & Packaging

Initial Therapeutics, Inc.; 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, ensuring deviations, change controls, and commissioning activities align with quality standards. This role requires on-site presence in manufacturing areas and collaboration across functions to drive continuous improvement and ensure patient safety.

Responsibilities include leading process team activities, validating equipment and systems, and maintaining quality metrics while supporting

Qualifications

• Bachelor's degree in a scientific field is required.
• 4+ years’ experience in Quality pharmaceutical manufacturing.
• Experience with C&Q/Verification and Validation oversight including automation and validation.

Responsibilities

• Active presence in operational areas.
• Quality oversight for verification and qualification of equipment, buildings, and systems.
• Guidance for deviations and change controls.
• Understand process and its equipment and operations.
• Lead annual quality floor time plan.
• Support batch documentation reviews and exceptions.
• Monitor asset qualification and monitoring reports.
• Respond to issues outside core hours.
• Provide updates at daily process team meetings.
• Mentor and train new Quality staff.
• Resolve or elevate compliance issues to Quality Management.
• Identify and implement continuous improvements.
• Measure and maintain quality metrics.
• Be a positive role model for the Process Team.

Skills

Quality knowledge

Cross-functional communication

SAP

Trackwise

MES

Automation knowledge

Education

Bachelor's degree in a scientific field

Tools

Automation validation

Computer systems validation

Job description

Lilly is seeking a Quality Assurance Process team member to lead and mentor operations on quality matters, ensuring deviations, change controls, and commissioning activities align with quality standards. This role requires on-site presence in manufacturing areas and collaboration across functions to drive continuous improvement and ensure patient safety.

Responsibilities include leading process team activities, validating equipment and systems, and maintaining quality metrics while supporting