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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 39,000 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.
The microbiologist performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. The microbiologist completes second person verification of others results. The microbiologist also participates in laboratory root cause investigations, equipment evaluations and qualifications, and some quality system improvement initiatives by executing well-defined protocols and procedures. The microbiologist shares technical information and best practice within plant sites or group
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 conformance 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.
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.
Contribute 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.
Develops equipment qualification protocols with appropriate guidance.
Perform routine equipment calibrations or maintenance through execution of well-defined protocols.
Comply with and implement safety standards.
Executes notification to management when required by procedures or standards.
Initiate change controls and deviations.
Train and mentoring others. Develop training materials
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
Bachelor (4 yr College) degree in microbiology or High School Diploma/GED with 7 or more yrs of demonstrated experience in a GMP microbiology lab.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Proficiency with computer systems including Microsoft Office products, LIMS (list other lab systems), etc.
Ability to working in a lab environment including wearing appropriate PPE and other safety required equipment and considerations.
Demonstrated strong math and documentation skills.
Demonstrated strong oral and written communication and interpersonal interaction skills.
8 hour days – Monday through Friday with potential for additional weekend work as required.
Minimal travel required.
Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position
Required to wear a pager/cell phone off shift and respond to operational issues.
Tasks may require repetitive motion (e.g., keyboarding).
Post-offer testing exam may be required.
This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.
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.
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