Lilly Biologist - Quality Control in Indianapolis, Indiana
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 35,000 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.
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 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 qualifications, 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.
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.
- Bachelor (4 yr College) degree in microbiology or 3 or more yrs of demonstrated relevant experience in a GMP (analytical chemistry, microbiology or biology) lab.
Proficiency with computer systems including Microsoft Office products, LIMS etc.
Previous GMP experience is preferred.
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.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
8 hour days – Monday through Friday
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 off shift and respond to operational issues.
Tasks may require repetitive motion (e.g., keyboarding).
Post-offer testing exam may be required.
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.
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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!