Analyst – QC Chemistry & Device
Eli Lilly and Company
6 months ago
On-site
Durham, NC
Operations
Responsibilities:
- Independently perform accurate and timely analytical testing of routine laboratory and stability samples per approved procedures, protocols, and GMP.
- Perform second person verification (SPV) and peer review of analytical data; ensure data integrity, cGMP, and site quality compliance.
- Record, review, and interpret analytical data in laboratory systems (e.g., LIMS) per procedures and GMP.
- Execute testing techniques including HPLC, UV-Vis, Capillary Electrophoresis (CE), device testing, compendial testing, and utilities testing (e.g., TOC, nitrates).
- Proactively identify deviations, atypical results, or out-of-trend data; initiate/support investigations.
- Author, review, and close analytical investigations, deviations, change controls, CAPAs, and related quality documentation.
- Troubleshoot analytical methods and laboratory equipment with minimal supervision.
- Author, revise, and review SOPs, protocols, and other controlled laboratory documents.
- Adhere to Environmental, Health, and Safety (EHS) standards and site policies.
- Contribute reliably on a small night-shift team with accountability and sound judgment.
Requirements:
- Bachelor’s degree (4-year college) in Chemistry, Biology, Microbiology, or related scientific discipline.
- Demonstrated experience in a GMP QC laboratory environment (routine analytical testing and data documentation).
- Experience working with minimal supervision in a regulated laboratory setting.
Preferred (Not Required):
- Experience supporting manufacturing or stability testing in a regulated environment.
- Experience with LIMS and Empower.
- Hands-on experience with HPLC, CE, device testing, and compendial methods.
- Experience performing SPV.
- Working knowledge of FDA regulations, cGMP, and compendial requirements.
- Experience in laboratory investigations, root cause analysis, and CAPA activities.
- Familiarity with Veeva Vault QMS (OneQMS) or similar systems.
- Strong attention to detail, communication, and organizational skills.
- Ability to work independently off-shift and collaborate across shifts.
- Experience with lean lab and 5S concepts.
Schedule / Additional Information:
- Night shift: 10-hour days, Sunday–Wednesday, 7:00 PM–5:30 AM.
- May require support outside the schedule for continuous (24/7) manufacturing operations.
- Minimal travel required.
Benefits (included in posting):
- Anticipated pay: $65,250–$169,400.
- Potential company bonus for full-time equivalent employees.
- Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance/death benefits, time off/leave, and well-being benefits (e.g., employee assistance, fitness, employee clubs/activities).
Application instruction (accommodation):
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
- Independently perform accurate and timely analytical testing of routine laboratory and stability samples per approved procedures, protocols, and GMP.
- Perform second person verification (SPV) and peer review of analytical data; ensure data integrity, cGMP, and site quality compliance.
- Record, review, and interpret analytical data in laboratory systems (e.g., LIMS) per procedures and GMP.
- Execute testing techniques including HPLC, UV-Vis, Capillary Electrophoresis (CE), device testing, compendial testing, and utilities testing (e.g., TOC, nitrates).
- Proactively identify deviations, atypical results, or out-of-trend data; initiate/support investigations.
- Author, review, and close analytical investigations, deviations, change controls, CAPAs, and related quality documentation.
- Troubleshoot analytical methods and laboratory equipment with minimal supervision.
- Author, revise, and review SOPs, protocols, and other controlled laboratory documents.
- Adhere to Environmental, Health, and Safety (EHS) standards and site policies.
- Contribute reliably on a small night-shift team with accountability and sound judgment.
Requirements:
- Bachelor’s degree (4-year college) in Chemistry, Biology, Microbiology, or related scientific discipline.
- Demonstrated experience in a GMP QC laboratory environment (routine analytical testing and data documentation).
- Experience working with minimal supervision in a regulated laboratory setting.
Preferred (Not Required):
- Experience supporting manufacturing or stability testing in a regulated environment.
- Experience with LIMS and Empower.
- Hands-on experience with HPLC, CE, device testing, and compendial methods.
- Experience performing SPV.
- Working knowledge of FDA regulations, cGMP, and compendial requirements.
- Experience in laboratory investigations, root cause analysis, and CAPA activities.
- Familiarity with Veeva Vault QMS (OneQMS) or similar systems.
- Strong attention to detail, communication, and organizational skills.
- Ability to work independently off-shift and collaborate across shifts.
- Experience with lean lab and 5S concepts.
Schedule / Additional Information:
- Night shift: 10-hour days, Sunday–Wednesday, 7:00 PM–5:30 AM.
- May require support outside the schedule for continuous (24/7) manufacturing operations.
- Minimal travel required.
Benefits (included in posting):
- Anticipated pay: $65,250–$169,400.
- Potential company bonus for full-time equivalent employees.
- Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance/death benefits, time off/leave, and well-being benefits (e.g., employee assistance, fitness, employee clubs/activities).
Application instruction (accommodation):
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.