Quality Assurance Process Team Device Assembly and Packaging

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

Benefits offered by this job

Bonus

401(k) plan

Pension plan

Medical insurance

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Well-being program

Job summary

Lilly is seeking a Quality professional to lead and mentor operations on quality matters across manufacturing areas. You will support deviations, change controls, validation activities, and asset qualification monitoring in a regulated environment.

The role requires a Bachelor’s degree in a scientific field and 4+ years in pharmaceutical quality. Experience with SAP, Trackwise, MES and computer systems validation is essential. Onsite work with potential on-call coverage is required.

Qualifications

• Bachelor’s or equivalent 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 computer systems validation.

Responsibilities

• Lead, mentor, and coach operations and support personnel on quality matters.
• Provide support on deviations, change controls, procedure updates, commissioning, and qualification activities.
• Maintain a regular presence in operational areas to monitor and confirm execution according to quality standards.
• Participate in the local process team for Device Assembly Packaging (DAP) or other manufacturing areas.
• Provide quality oversight for equipment, buildings, test cases, discrepancy resolution, and asset qualification monitoring.
• Respond to operational issues outside core business hours and attend quality process team meetings.
• Mentor and train new Quality staff, identify and implement continuous improvements, and measure quality metrics.

Skills

Quality oversight

Regulatory knowledge

SAP

Trackwise

MES

Computer systems validation

Education

Bachelor’s or equivalent degree in a scientific field

Tools

SAP

Trackwise

MES

Computer systems

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. Headquartered in Indianapolis, Indiana, we are a global healthcare leader dedicated to discovering and delivering life‑changing medicines.

Responsibilities

• Lead, mentor, and coach operations and support personnel on quality matters.
• Provide support on deviations, change controls, procedure updates, commissioning, and qualification activities.
• Maintain a regular presence in operational areas to monitor and confirm execution according to quality standards.
• Participate in the local process team for Device Assembly Packaging (DAP) or other manufacturing areas.
• Provide quality oversight for equipment, buildings, test cases, discrepancy resolution, and asset qualification monitoring.
• Respond to operational issues outside core business hours and attend quality process team meetings.
• Mentor and train new Quality staff, identify and implement continuous improvements, and measure quality metrics.

Qualifications

• Bachelor’s or equivalent degree in a scientific field.
• 4+ years’ experience in quality pharmaceutical manufacturing.
• Experience with C&Q / Verification and Validation oversight, including automation and computer systems validation.
• Knowledge of US, EU, Japan, and other pharmaceutical manufacturing regulations.
• Excellent communication skills, ability to work independently as a Quality SME.
• Proficiency with SAP, Trackwise, MES, and other computer systems.
• Ability to work 8‑hour onsite shifts, overtime as required; not eligible for remote work.
• Legal authorization to be employed in the United States; no visa sponsorship provided.

Additional Skills/Preferences

• ASQ Certified CSQA experience.
• Experience with device assembly or packaging.
• Experience with Manufacturing Execution Systems.
• Experience with KNEAT or other electronic validation software.
• Technical writing experience.

Benefits

Actual compensation will depend on education, experience, skills, and geographic location. The anticipated wage for this position is $65,250–$169,400. Full‑time employees are eligible for a company bonus, a company‑sponsored 401(k) and pension plans, vacation benefits, medical, dental, vision, and prescription drug benefits, flexible benefits such as health‑care and dependent day‑care flexible spending accounts, life insurance, death benefits, certain time‑off and leave of absence benefits, and well‑being benefits including an employee assistance program, fitness benefits, and employee clubs and activities.

EEO Statement

Lilly is proud to be an Equal Employment Opportunity (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.

Accommodation Statement

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. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.