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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. Majority of the Biologist time is spent in the laboratory performing assays and releasing results.

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.

• Perform Bioassay testing using manual and automation techniques.

• 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).

• Experience with Cell based Bioassay methods using microplate assay formats and Cell Cultures.

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

• Ability to work in a team 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.

Additional Preferences:

• Experience with Cell based Bioassay methods and Cell Cultures

• Previous experience with Lilly deviation and change control process.

• 2 years laboratory experience in GMP QC Laboratory environment.

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

Other Information:

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

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

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

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

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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 ( LillyRecruitingCompliance@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.

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