Lead Process Technician - QA Floor Support
Eli Lilly and Company
4 days ago
On-site
Durham, NC
Operations
Job Responsibilities
- Provide daily quality oversight/support for GMP parenteral operations (Raleigh-Durham, NC), including formulation, filling, and visual inspection.
- Maintain a safe work environment; support HSE corporate/site goals.
- Monitor GMP programs/quality systems; ensure adherence to good documentation practices.
- Retrieve/review quality documents and coordinate delivery to supported areas.
- Support AQL visual inspection.
- Review/approve GMP documentation (e.g., cycle summary reports, electronic batch record initiation, daily floor quality documentation, maintenance action plans, RTService/Release and HOLDs, work order assessments, procedures/protocols/production record instructions).
- Identify potential product quality impact; assess whether observations are required.
- Conduct Aseptic Process Simulation 14-day read observations and supporting aseptic observations.
- Reconcile QA issues across systems (SAP, PMX, TrackWise, Veeva, GMARS, others as required) and ensure manufacturing areas receive needed QA support.
Basic Requirements
- High School/GED minimum; demonstrated aseptic pharmaceutical experience.
- Associate degree in science/engineering/computer/pharmaceutical field (preferred).
- Strong communication/interpersonal skills; attention to detail.
- TrackWise deviation/change management experience.
- Authorized to work in the U.S. full-time; Lilly will not sponsor visas.
- Complete post-offer exam/work simulation if applicable; ability to work overtime.
Additional Preferences
- Production QA/QC and Visual Inspection experience.
- Bachelor’s preferred; knowledge of pharmaceutical process/Quality Systems; validation/qualification knowledge; GMP production and facility/area start-up experience; problem-solving/independent/team capability.
Shift/Scheduling
- Night shift/24-7 rotating 12-hour schedule; onboarding starts with 8 hours Mon–Fri days; mandatory overtime may be required.
Pay/Benefits (as stated)
- Anticipated wage: $28.84–$46.54; eligible for company bonus.
- Eligible for 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time-off/leave benefits, and well-being benefits.
- Provide daily quality oversight/support for GMP parenteral operations (Raleigh-Durham, NC), including formulation, filling, and visual inspection.
- Maintain a safe work environment; support HSE corporate/site goals.
- Monitor GMP programs/quality systems; ensure adherence to good documentation practices.
- Retrieve/review quality documents and coordinate delivery to supported areas.
- Support AQL visual inspection.
- Review/approve GMP documentation (e.g., cycle summary reports, electronic batch record initiation, daily floor quality documentation, maintenance action plans, RTService/Release and HOLDs, work order assessments, procedures/protocols/production record instructions).
- Identify potential product quality impact; assess whether observations are required.
- Conduct Aseptic Process Simulation 14-day read observations and supporting aseptic observations.
- Reconcile QA issues across systems (SAP, PMX, TrackWise, Veeva, GMARS, others as required) and ensure manufacturing areas receive needed QA support.
Basic Requirements
- High School/GED minimum; demonstrated aseptic pharmaceutical experience.
- Associate degree in science/engineering/computer/pharmaceutical field (preferred).
- Strong communication/interpersonal skills; attention to detail.
- TrackWise deviation/change management experience.
- Authorized to work in the U.S. full-time; Lilly will not sponsor visas.
- Complete post-offer exam/work simulation if applicable; ability to work overtime.
Additional Preferences
- Production QA/QC and Visual Inspection experience.
- Bachelor’s preferred; knowledge of pharmaceutical process/Quality Systems; validation/qualification knowledge; GMP production and facility/area start-up experience; problem-solving/independent/team capability.
Shift/Scheduling
- Night shift/24-7 rotating 12-hour schedule; onboarding starts with 8 hours Mon–Fri days; mandatory overtime may be required.
Pay/Benefits (as stated)
- Anticipated wage: $28.84–$46.54; eligible for company bonus.
- Eligible for 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time-off/leave benefits, and well-being benefits.