Quality Assurance - Floor Support Specialist
Eli Lilly and Company
12 hours ago
On-site
Pleasant Prairie, WI
Operations
Responsibilities / Position Overview
- Provide QA oversight to GMP operations in parenteral equipment preparation, formulation, filling, and visual inspection areas.
- Ensure compliance and QA presence to monitor aseptic behaviors, GMP programs, and quality systems.
- Adhere to safety rules and support HSE goals; maintain a safe work environment.
- Ensure training is completed and compliant.
- Communicate quality/operational issues with QA Process Team Leaders and the AD of QA Parenteral Operations.
- Apply good documentation practices for Operations and Support personnel.
- Review/approve GMP documentation (e-batch record logs, paper logbooks, cleaning, and procedures vs. performance).
- Perform daily documented Quality Checks.
- Collect, inspect, and deliver samples to storage and/or laboratory.
- Troubleshoot and support QA systems (e.g., SAP inventory control, Darwin LIMS; TrackWise/PMX, Master Control, Veeva).
- Support self-led and internal/external regulatory inspections.
- Work cross-functionally.
Basic Qualifications
- High School Diploma or equivalent.
- Legally authorized to work in the United States; no sponsorship anticipated (visa examples listed in posting).
- Post-offer exam or work simulation completion (if applicable).
- Ability to work overtime.
Preferred/Additional Skills
- Strong oral/written communication and interpersonal skills.
- Bachelor’s degree (science/engineering/computer/pharmaceutical), preferred.
- Knowledge of pharmaceutical processes and Quality Systems; SAP/deviations systems.
- GMP production experience; validation/qualification knowledge.
- Combination product/device experience; US/EU regulatory exposure; startup experience; strong problem-solving and attention to detail.
Compensation/Benefits
- Anticipated wage: $18.02–$34.90; eligible for company bonus and comprehensive benefits (including 401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, and well-being benefits).
Additional Information
- May respond to operational issues outside core hours; may work in various areas within DAP and Warehouse buildings.
- Provide QA oversight to GMP operations in parenteral equipment preparation, formulation, filling, and visual inspection areas.
- Ensure compliance and QA presence to monitor aseptic behaviors, GMP programs, and quality systems.
- Adhere to safety rules and support HSE goals; maintain a safe work environment.
- Ensure training is completed and compliant.
- Communicate quality/operational issues with QA Process Team Leaders and the AD of QA Parenteral Operations.
- Apply good documentation practices for Operations and Support personnel.
- Review/approve GMP documentation (e-batch record logs, paper logbooks, cleaning, and procedures vs. performance).
- Perform daily documented Quality Checks.
- Collect, inspect, and deliver samples to storage and/or laboratory.
- Troubleshoot and support QA systems (e.g., SAP inventory control, Darwin LIMS; TrackWise/PMX, Master Control, Veeva).
- Support self-led and internal/external regulatory inspections.
- Work cross-functionally.
Basic Qualifications
- High School Diploma or equivalent.
- Legally authorized to work in the United States; no sponsorship anticipated (visa examples listed in posting).
- Post-offer exam or work simulation completion (if applicable).
- Ability to work overtime.
Preferred/Additional Skills
- Strong oral/written communication and interpersonal skills.
- Bachelor’s degree (science/engineering/computer/pharmaceutical), preferred.
- Knowledge of pharmaceutical processes and Quality Systems; SAP/deviations systems.
- GMP production experience; validation/qualification knowledge.
- Combination product/device experience; US/EU regulatory exposure; startup experience; strong problem-solving and attention to detail.
Compensation/Benefits
- Anticipated wage: $18.02–$34.90; eligible for company bonus and comprehensive benefits (including 401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, and well-being benefits).
Additional Information
- May respond to operational issues outside core hours; may work in various areas within DAP and Warehouse buildings.