Biologist – QC – IAPI - Eli Lilly and Company

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description:

The biologist – QC - IAPI performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines.  The biologist completes second person verification of others results.  The biologist 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 biologist shares technical information and best practice within plant sites or group.

Key Objectives/Deliverables:

Sample Analysis and Reporting

• 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.

• 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.

Problem Solving

• 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.

Continuous Improvement Initiatives

• 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.

Lab Operations

• 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.

Basic Requirements:

• Bachelor degree (4 year College) in a science field related to the lab (e.g., chemistry for chem. Labs or micro or biology for micro lab)

• Proficiency with computer systems LIMS, Excel, Statistical tools, etc.

Additional Preferences:

• Previous experience with Lilly deviation and change control process.

• 2 years laboratory experience in GMP QC Laboratory environment

• Experience with Microbiological, Bioassay and ELISA testing methods

• 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.

• Flexibility in regards to work schedule and job responsibilities to meet business needs

Other Information:

• Must complete applicable Learning Plan for Biologist/Microbiologist – QC – IAPI.

• Tasks may require repetitive motion and standing for long periods of time.

• Applicant may work and be cross trained in various labs within the IAPI. 

• May be required to provide 24 hour cell coverage, as necessary.

• Overtime, after business hours or weekend work required, as necessary.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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