Chemist QC IAPI
Eli Lilly and Company
2 hours ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Serve as data steward for analytical data; provide technical support for reliable, compliant manufacture of bulk drug substance to global quality standards.
- Review and interpret laboratory results; perform non-routine laboratory work.
- Use technical skills for problem solving, continuous improvement, and thorough investigations of atypical data/results; produce conclusions, action plans, and/or technical documents.
- Provide technical mentoring; share best practices within the work group and across plant sites; influence technical agenda.
- Develop/monitor statistically based real-time metrics for analytical vs. process variability and capability.
- Support non-routine investigations (e.g., deviations) and prepare technical documents (change controls, deviations, validation protocols, tickets, procedures, PFDs, periodic quality evaluations, etc.).
- Support production operations via change proposals, investigations, and deviation root-cause analysis; maintain/improve quality systems and method remediation.
- Manage review/retention of cGMP documents; follow ALCOA+ data integrity.
Basic Requirements:
- Bachelor’s degree in a science-related field OR 7+ years in a GMP laboratory.
- Authorized to work in the U.S. full-time; Lilly does not sponsor visas/work authorization.
Preferences:
- Problem solving/analytical skills; statistical tools knowledge; strong written/verbal skills; attention to detail; ability to organize/prioritize; experience in QA/QC, manufacturing, tech services, or regulatory affairs; cGMP knowledge.
Benefits (if eligible):
- Company bonus; 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Other:
- Complete applicable learning plan; wear PPE in manufacturing/lab areas; overtime/on-call may be required; on-site unless leadership approves otherwise.
- Serve as data steward for analytical data; provide technical support for reliable, compliant manufacture of bulk drug substance to global quality standards.
- Review and interpret laboratory results; perform non-routine laboratory work.
- Use technical skills for problem solving, continuous improvement, and thorough investigations of atypical data/results; produce conclusions, action plans, and/or technical documents.
- Provide technical mentoring; share best practices within the work group and across plant sites; influence technical agenda.
- Develop/monitor statistically based real-time metrics for analytical vs. process variability and capability.
- Support non-routine investigations (e.g., deviations) and prepare technical documents (change controls, deviations, validation protocols, tickets, procedures, PFDs, periodic quality evaluations, etc.).
- Support production operations via change proposals, investigations, and deviation root-cause analysis; maintain/improve quality systems and method remediation.
- Manage review/retention of cGMP documents; follow ALCOA+ data integrity.
Basic Requirements:
- Bachelor’s degree in a science-related field OR 7+ years in a GMP laboratory.
- Authorized to work in the U.S. full-time; Lilly does not sponsor visas/work authorization.
Preferences:
- Problem solving/analytical skills; statistical tools knowledge; strong written/verbal skills; attention to detail; ability to organize/prioritize; experience in QA/QC, manufacturing, tech services, or regulatory affairs; cGMP knowledge.
Benefits (if eligible):
- Company bonus; 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Other:
- Complete applicable learning plan; wear PPE in manufacturing/lab areas; overtime/on-call may be required; on-site unless leadership approves otherwise.