Chemist QC IAPI
Eli Lilly and Company
19 days ago
On-site
Indianapolis, IN
Operations
Position: Chemist – QC – IAPI
Responsibilities / Role Duties
- Perform accurate, timely routine and some non-routine testing of lab samples in accordance with GMP and safety guidelines.
- Complete second-person verification of other analysts’ results.
- Participate in laboratory root cause investigations, equipment evaluations and qualification, and some quality system improvement initiatives.
- Share technical information and best practices within plant sites or the group.
Key Objectives / Deliverables
Sample Analysis and Reporting
- Verify (SPV) analytical data of other analysts as requested.
- Perform analytical test methods and related support activities per procedures/protocols (HPLC, UPLC, CG).
- Enter and review data for accuracy per laboratory procedures, standards, and GMP requirements; may perform holistic review for data release.
Problem Solving
- Recognize deviations and initiate/participate in Root Cause Investigations; troubleshoot equipment and methods as required.
Continuous Improvement
- Improve quality systems by creating/revising lab documentation; identify and communicate improvement opportunities.
- Contribute to development of PQEs; review SOPs for being executable as written.
Lab Operations
- Write protocols for non-routine testing/validation; develop equipment qualification protocols.
- Perform routine equipment calibrations/maintenance; comply with safety standards.
- Execute required management notifications; initiate change controls/deviations.
- Train and mentor others; develop training materials.
Basic Requirements
- Bachelor’s degree in Chemistry (or 7–10 years relevant experience in a GMP analytical lab).
- Proficiency with LIMS, Empower, Excel.
- Ability to work in a lab with PPE/safety equipment.
- Strong math and documentation; strong oral/written communication and interpersonal skills.
- Authorized to work in the U.S. on a full-time basis (no sponsorship).
Additional Preferences
- Experience with deviation and change control.
Other Information
- Complete applicable Learning Plan for Chemist – QC – IAPI.
- Tasks may involve repetitive motion/standing; lift at least 5 liters; overtime/weekend work as needed.
Responsibilities / Role Duties
- Perform accurate, timely routine and some non-routine testing of lab samples in accordance with GMP and safety guidelines.
- Complete second-person verification of other analysts’ results.
- Participate in laboratory root cause investigations, equipment evaluations and qualification, and some quality system improvement initiatives.
- Share technical information and best practices within plant sites or the group.
Key Objectives / Deliverables
Sample Analysis and Reporting
- Verify (SPV) analytical data of other analysts as requested.
- Perform analytical test methods and related support activities per procedures/protocols (HPLC, UPLC, CG).
- Enter and review data for accuracy per laboratory procedures, standards, and GMP requirements; may perform holistic review for data release.
Problem Solving
- Recognize deviations and initiate/participate in Root Cause Investigations; troubleshoot equipment and methods as required.
Continuous Improvement
- Improve quality systems by creating/revising lab documentation; identify and communicate improvement opportunities.
- Contribute to development of PQEs; review SOPs for being executable as written.
Lab Operations
- Write protocols for non-routine testing/validation; develop equipment qualification protocols.
- Perform routine equipment calibrations/maintenance; comply with safety standards.
- Execute required management notifications; initiate change controls/deviations.
- Train and mentor others; develop training materials.
Basic Requirements
- Bachelor’s degree in Chemistry (or 7–10 years relevant experience in a GMP analytical lab).
- Proficiency with LIMS, Empower, Excel.
- Ability to work in a lab with PPE/safety equipment.
- Strong math and documentation; strong oral/written communication and interpersonal skills.
- Authorized to work in the U.S. on a full-time basis (no sponsorship).
Additional Preferences
- Experience with deviation and change control.
Other Information
- Complete applicable Learning Plan for Chemist – QC – IAPI.
- Tasks may involve repetitive motion/standing; lift at least 5 liters; overtime/weekend work as needed.