Current jobs related to Biologist - QC - IAPI - Indianapolis, Indiana - Eli Lilly and Company

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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.

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.

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