Scientist Quality Assurance
Eli Lilly and Company
June 27, 2026
Remote friendly (Durham, NC)
United States
Operations
Responsibilities:
- Provide quality oversight for parenteral formulation/filling using isolator technology and/or visual inspection processes.
- Support non-conformance investigations, change control proposals, procedure/master formula revisions, validations, sterility assurance, commissioning, and qualification activities.
- Cross-train in visual inspection to support a collaborative quality/production environment.
- Review/approve GMP documents (non-conformances, procedures, protocols, specifications, change controls).
- Lead/mentor/coach operations and support personnel on quality matters.
- Assess and triage deviations/observations in drug product formulation, filling, and visual inspection.
- Represent Quality on plant/process improvement initiatives.
- Liaison with internal support groups and external partners on product-related issues.
- Participate in self-led inspections; support internal/external regulatory inspections.
- Maintain safety compliance (HSE) for self and others.
Basic Requirements:
- Bachelor’s degree (preferred Science or Engineering).
Additional Skills/Preferences:
- 3+ years demonstrated GMP facility experience.
- Knowledge of aseptic manufacturing, isolator technology, visual inspection, and Quality Systems.
- Root cause analysis/troubleshooting; strong communication and teamwork.
- Technical decision-making and ability to guide/lead.
- Prior regulatory inspection readiness/execution.
- Proficiency: PMX (or similar), SAP (or similar), LIMS, TrackWise (or similar), change management; Microsoft Office.
- CQA (ASQ) or CSQA experience.
Additional Information:
- Support 24/7 manufacturing operation; remote 2–4 days/month.
- Pay range: $65,250–$148,500; eligible for company bonus.
- Benefits include 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
- Provide quality oversight for parenteral formulation/filling using isolator technology and/or visual inspection processes.
- Support non-conformance investigations, change control proposals, procedure/master formula revisions, validations, sterility assurance, commissioning, and qualification activities.
- Cross-train in visual inspection to support a collaborative quality/production environment.
- Review/approve GMP documents (non-conformances, procedures, protocols, specifications, change controls).
- Lead/mentor/coach operations and support personnel on quality matters.
- Assess and triage deviations/observations in drug product formulation, filling, and visual inspection.
- Represent Quality on plant/process improvement initiatives.
- Liaison with internal support groups and external partners on product-related issues.
- Participate in self-led inspections; support internal/external regulatory inspections.
- Maintain safety compliance (HSE) for self and others.
Basic Requirements:
- Bachelor’s degree (preferred Science or Engineering).
Additional Skills/Preferences:
- 3+ years demonstrated GMP facility experience.
- Knowledge of aseptic manufacturing, isolator technology, visual inspection, and Quality Systems.
- Root cause analysis/troubleshooting; strong communication and teamwork.
- Technical decision-making and ability to guide/lead.
- Prior regulatory inspection readiness/execution.
- Proficiency: PMX (or similar), SAP (or similar), LIMS, TrackWise (or similar), change management; Microsoft Office.
- CQA (ASQ) or CSQA experience.
Additional Information:
- Support 24/7 manufacturing operation; remote 2–4 days/month.
- Pay range: $65,250–$148,500; eligible for company bonus.
- Benefits include 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.