Chemist – QC – IAPI

Eli Lilly and Company•Us, IN

10h

About The Position

The Chemist – QC – IAPI performs accurate, timely, and safe routine laboratory testing in accordance with GMP requirements, safety guidelines, procedures, and protocols. The role reviews and interprets laboratory results, enters and checks data for accuracy, and conducts second-person verification of other analysts’ analytical data. It also supports laboratory investigations, equipment calibration and maintenance, method remediation, and continuous improvement initiatives. The Chemist uses technical expertise to troubleshoot methods and equipment, solve moderately complex problems, investigate atypical data, and support non-routine projects. The position develops and responds to statistically based metrics to assess analytical and process variability and capability, and supports manufacturing through change proposals, investigations, and root-cause analysis. The Chemist also helps maintain quality systems, contributes to self-assessments and regulatory inspections, and works to meet internal and external quality and supply commitments. The role includes technical mentoring and sharing best practices within the work group and across plant sites, as well as participating in and influencing the technical agenda of the plant or corporation. Work requires entering manufacturing and laboratory areas and wearing appropriate personal protective equipment. The position may require on-call support and operates on a 12-hour rotating schedule supporting a 24/7/365 operation, with shifts from 5:45 a.m. to 6:00 p.m. on a 3-2-2-3 schedule.

Requirements

Bachelor’s degree in science or two years of experience in a chemistry-based laboratory.
Two years of analytical chemistry laboratory experience in a GMP-regulated environment.
Ability to apply advanced techniques and address moderately complex technical challenges.
Ability to lift at least 5 liters of liquid.
Must complete applicable Learning Plan tasks.
Must be authorized to work in the United States on a full-time basis; the employer will not sponsor work authorization or visas for this role.
Must be able to work a 12-hour rotating shift on a 3-2-2-3 schedule, supporting a 24/7/365 operation.

Nice To Haves

Bachelor’s degree in chemistry, analytical chemistry, or biochemistry.
Strong problem-solving and analytical-thinking skills.
Understanding of statistical tools and analysis.
Excellent interpersonal and networking skills.
Experience in QA, QC, Manufacturing, Technical Services, or Regulatory Affairs.
Strong written and verbal communication skills.
Strong attention to detail.
Ability to organize and prioritize multiple tasks.

Responsibilities

Accurately and safely perform analytical test methods and related support activities according to procedures and protocols.
Review analytical results to ensure they conform to standards; enter data and check one’s own work for accuracy and GMP compliance.
Recognize procedural deviations and initiate investigations.
Perform second-person verification of analytical data produced by other analysts.
Identify and communicate opportunities for improvement and troubleshoot equipment and methods.
Train and mentor laboratory staff where applicable.
Notify management when required by procedures or standards.
Apply scientific principles relevant to manufacturing and testing intermediates and bulk drug substances, including interactions between chemistry and equipment.
Develop and monitor statistically based metrics and respond appropriately to assess analytical and process variability and capability.
Provide technical support for non-routine investigations, including deviation investigations.
Support production-floor operations through change proposals, investigations, and deviation root-cause analysis.
Maintain and improve quality systems, including method remediation.
Participate in self-assessments and regulatory agency inspections.
Help ensure internal and external quality and supply commitments are met.
Review and interpret laboratory results and initiate analytical method re-evaluations based on laboratory data and monitoring of Proven Important Factors.
Perform non-routine laboratory work in support of projects.
Complete thorough investigations of atypical data and results and document results, conclusions, action plans, and technical documents.
Share technical information and best practices within the work group and across plant sites, and contribute to the technical agenda of the plant or corporation.

Benefits

Company bonus for eligible full-time equivalent employees, depending in part on company and individual performance.
Company-sponsored 401(k) participation eligibility.
Pension.
Vacation benefits.
Medical, dental, vision, and prescription drug benefit eligibility.
Flexible benefits, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.
Employee resource groups open to all employees.