Chemist QC IAPI

Eli Lilly and CompanyUs, IN
Onsite

About The Position

The Chemist – QC - IAPI performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. The chemist completes second person verification of others results. The chemist also participates in laboratory root cause investigations, equipment evaluations and qualification, and some quality system improvement initiatives by executing well-defined protocols and procedures. The chemist shares technical information and best practice within plant sites or group.

Requirements

  • Bachelor’s degree (4 yr College) in a Chemistry or 7-10 years of demonstrated relevant experience in a GMP (analytical) lab
  • Proficiency with computer systems LIMS, Empower, Excel, etc.
  • Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations
  • Demonstrate strong math and documentation skills
  • Demonstrate strong oral and written communication and interpersonal interaction skills
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

  • Previous experience with deviation and change control process.

Responsibilities

  • Verify (SPV) analytical data of other analysts within the lab as requested
  • Accurately and safely perform analytical test methods or related support activities as per procedures or protocols.
  • Uses technical knowledge in the review and interpretation of data for conformances to procedures, standards and protocols and/or real-time recognition of aberrant data and results (HPLC, UPLC, and CG instruments and methods)
  • Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards and GMP requirements
  • May perform holistic review of data for release of data from the laboratory
  • Recognizes when a deviation from procedures, etc has occurred and initiates and participates in a Root Cause Investigation
  • Performs investigations for deviations
  • Troubleshoot equipment and methods as required
  • Assist in improvement of quality systems by creating or revising worksheets and other lab documentation systems
  • Identifies and communicates opportunities for improvement initiatives in daily work activities
  • Contributes to development of PQEs
  • Reviews SOPs for executable as written
  • Shares technical information and best practice within plant sites or group
  • Write protocols for non-routine testing or validation with appropriate guidance
  • Develop equipment qualification protocols with appropriate guidance
  • Perform routine equipment calibrations or maintenance
  • Comply with and implement safety standards
  • Execute notification to management when required by procedures or standards
  • Initiate change controls and deviations
  • Train and mentor others.
  • Develop training materials

Benefits

  • company bonus (depending, in part, on company and individual performance)
  • company-sponsored 401(k)
  • pension
  • vacation benefits
  • medical, dental and vision and prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance and death benefits
  • certain time off and leave of absence benefits
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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