Quality Assurance Senior Specialist - Statistical Sorting
Eli Lilly and Company
August 20, 2026
On-site
Pleasant Prairie, WI
Operations
Position Overview
- QA – Stat Sort Sr. Specialist to oversee daily Stat Sort operations, develop QA Stat Sort Assistants, manage daily batch scheduling, support deviation investigations, change control proposals, procedures, training, and serve as inspection SME. Provide QA support for start-up, commissioning, and qualification of the Kenosha site.
Responsibilities
- Maintain a safe work environment and support all HSE corporate/site goals.
- Manage Syringe Defect Kits (Automated Inspection Challenge kits and Inspection Qualification kits).
- Function as Leader in Leader’s absence.
- Assist in development of QA Stat Sort Assistants.
- Plan/schedule QA Stat Sort operations; act as technical resource.
- Review GMP documents (non-conformances, procedures, protocols, change controls).
- Assess product quality impact of GMP incidents; support investigations and safety investigations.
- Ensure Good Documentation practices and compliance with work instructions.
- Perform syringe inspections.
- Participate in Six Sigma/process improvement initiatives.
- Oversee and assist training of new parenteral site visual inspectors.
Minimum Requirements
- High school diploma/equivalent.
- Relevant GMP facility experience.
- Strong interpersonal skills/teamwork; organization; quick learning; autonomous; positive/flexible.
- Microsoft Office (incl. Outlook).
- Pass eye exam (20/20 correctible; color blindness free).
- US work authorization required (no visa sponsorship).
Additional Skills/Preferences
- Parenteral visual inspection; deviation/change control experience; cGMP/data integrity knowledge; mentoring/training; strong technical writing/communication.
Benefits/Compensation (as stated)
- Anticipated wage: $18.02–$34.90; bonus eligibility; 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, certain time off/leave, and well-being benefits.
Additional Information
- Primary location: Kenosha County, Wisconsin; overtime/off-shift support may be required; lift up to 30 lbs.
- QA – Stat Sort Sr. Specialist to oversee daily Stat Sort operations, develop QA Stat Sort Assistants, manage daily batch scheduling, support deviation investigations, change control proposals, procedures, training, and serve as inspection SME. Provide QA support for start-up, commissioning, and qualification of the Kenosha site.
Responsibilities
- Maintain a safe work environment and support all HSE corporate/site goals.
- Manage Syringe Defect Kits (Automated Inspection Challenge kits and Inspection Qualification kits).
- Function as Leader in Leader’s absence.
- Assist in development of QA Stat Sort Assistants.
- Plan/schedule QA Stat Sort operations; act as technical resource.
- Review GMP documents (non-conformances, procedures, protocols, change controls).
- Assess product quality impact of GMP incidents; support investigations and safety investigations.
- Ensure Good Documentation practices and compliance with work instructions.
- Perform syringe inspections.
- Participate in Six Sigma/process improvement initiatives.
- Oversee and assist training of new parenteral site visual inspectors.
Minimum Requirements
- High school diploma/equivalent.
- Relevant GMP facility experience.
- Strong interpersonal skills/teamwork; organization; quick learning; autonomous; positive/flexible.
- Microsoft Office (incl. Outlook).
- Pass eye exam (20/20 correctible; color blindness free).
- US work authorization required (no visa sponsorship).
Additional Skills/Preferences
- Parenteral visual inspection; deviation/change control experience; cGMP/data integrity knowledge; mentoring/training; strong technical writing/communication.
Benefits/Compensation (as stated)
- Anticipated wage: $18.02–$34.90; bonus eligibility; 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, certain time off/leave, and well-being benefits.
Additional Information
- Primary location: Kenosha County, Wisconsin; overtime/off-shift support may be required; lift up to 30 lbs.